BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MINI ANCHOR

    MDR report key: 9191658 · Received October 15, 2019

    Report

    Report Number
    1221934-2019-58984
    Event Type
    Injury
    Date Received
    October 15, 2019
    Report Date
    October 11, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. [(B)(4)].

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: FAIRHURST, M. AND HANSEN, L. (2002), TREATMENT OF "GAMEKEEPER'S THUMB" BY RECONSTRUCTION OF THE ULNAR COLLATERAL LIGAMENT, JOURNAL OF HAND SURGERY, VOL 6, PAGES 542-545 (NEW ZEALAND). THE STUDY EMPHASIZES ON THE TREATMENT OF 22 THUMBS WITH SYMPTOMATIC LAXITY OF THE ULNAR COLLATERAL LIGAMENT OF THE METACARPOPHALANGEAL JOINT BY LIGAMENT RECONSTRUCTION 1 WEEK TO 10 YEARS AFTER INJURY. BETWEEN JANUARY 1994 AND JUNE 1997, A TOTAL OF 21 PATIENTS (14 MALES AND 7 FEMALES) WITH A MEAN AGE OF 34 (RANGE, 16 TO 24) WERE TREATED WITH A BONE ANCHOR (MINI MITEK, ETHICON, INC. JOHNSON AND JOHNSON, (B)(4), USA) AND A 2-0 POLYETHYLENE TEREPHTHALATE (ETHIBOND EXCEL). THE PATIENTS WERE REVIEWED 6 MONTHS TO 3 YEARS (MEAN, 16 MONTHS) AFTER SURGERY. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: FUNCTIONAL STABILITY OF THE METACARPOPHALANGEAL JOINT WAS REGAINED IN ALL BUT 1 THUMB, ALTHOUGH 5 RECONSTRUCTIONS WERE SLIGHTLY LAX AT FINAL FOLLOW-UP. 1 SIMPLE LIGAMENT PLICATION PERFORMED MORE THAN 8 WEEKS POST-INJURY SUFFERED A FURTHER INJURY 2 MONTHS AFTER SURGERY AND RUPTURED. AN EXTENSOR POLLICIS BREVIS RECONSTRUCTION WAS THEN CARRIED OUT BUT THE JOINT REMAINED PAINFUL AND THE PATIENT LATER HAD A JOINT FUSION. 5 PATIENTS EXPERIENCED PERSISTENT ACHING OF THE METACARPOPHALANGEAL JOINT WHEN PINCHING, BUT THIS WAS MILD AND NOT DISABLING. 2 OF THESE PATIENTS HAD SURGERY LESS THAN 8 WEEKS, AND 3 MORE THAN 8 WEEKS, AFTER INJURY. IN 1 PATIENT, DAMAGE TO A BRANCH OF THE SUPERFICIAL RADIAL NERVE RESULTED IN A PAINFUL NEUROMA ON THE DORSO-ULNA ASPECT OF THE THUMB. THIS WAS BURIED WITHIN THE FIRST DORSAL INTEROSSEOUS MUSCLE. ANOTHER PATIENT, WHO UNDERWENT SIMPLE LIGAMENT REPAIR MORE THAN 8 WEEKS AFTER SURGERY, STILL EXPERIENCED PAIN 8 MONTHS POST-SURGERY BUT DECLINED FURTHER SURGERY. 18 THUMBS (EXCLUDING THE FUSED THUMB) REGAINED FULL EXTENSION, BUT 14 HAD SLIGHTLY REDUCED FLEXION AT BOTH THE METACARPOPHALANGEAL AND INTERPHALANGEAL JOINTS. THESE PATIENTS COULD ALSO ONLY OPPOSE THE THUMB TIP TO THE BASE OF THE LITTLE FINGER AND NOT TO THE DISTAL PALMAR CREASE. 5 PATIENTS HAD REDUCED POWER GRIP, 2 OF WHOM ALSO HAD ONGOING METACARPOPHALANGEAL JOINT PAIN. 1 PATIENT WITH A COEXISTING SCAPHOID NONUNION HAD REDUCED GRIP SECONDARY TO THIS RATHER THAN HIS THUMB INJURY. KEY PINCH WAS EQUAL TO THE UNINJURED THUMB IN THE 8 OF THE EARLY REPAIRS AND IN 8 OF THE LATE REPAIRS WAS WITHIN 2 KG OF THE OPPOSITE SIDE. KEY PINCH WAS FUNCTIONAL IN ALL CASES. 4 PATIENTS HAD A TRANSIENT NEURAPRAXIA OF THE BRANCH OF THE SUPERFICIAL RADIAL NERVE. NEITHER OF THE 2 PATIENTS WHO UNDERWENT EPB RECONSTRUCTIONS SUFFERED ANY COMPLICATION AS A RESULT OF LOSS OF THE EPB FUNCTION. ALL BUT 1 PATIENT GRADED THEMSELVES AS SATISFIED OR VERY SATISFIED WITH THE RESULT. THIS REPORT IS FOR A BONE ANCHOR (MINI MITEK, ETHICON, INC. JOHNSON AND JOHNSON, (B)(4), USA) AND A 2-0 POLYETHYLENE TEREPHTHALATE (ETHIBOND EXCEL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985353 UNKNOWN MINI ANCHOR SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE HWC DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1