ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN
Report
- Report Number
- 2210968-2018-75054
- Event Type
- Injury
- Date Received
- August 9, 2018
- Report Date
- August 1, 2018
- Manufacturer
- ETHICON INC.
- Product Code
- GAT
- PMA / PMN Number
- K946173
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- OTHER
Narratives
(B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: EUR J ORTHOP SURG TRAUMATOL (2015) 25:1131¿1139, DOI 10.1007/S00590-015-1669-3, PUBLISHED ONLINE: 12 JULY 2015 - [(B)(4)].
IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE : FUNCTIONAL OUTCOMES AND COMPLICATIONS AFTER SURGICAL REPAIR OF TRICEPS TENDON RUPTURE" AUTHOR: OZKAN KOSE, OMER FARUK KILICASLAN, FERHAT GULER, BAVER ACAR, HALIL YALC¸IN YUKSEL. CITATION: EUR J ORTHOP SURG TRAUMATOL (2015) 25:1131¿1139, DOI 10.1007/S00590-015-1669-3, PUBLISHED ONLINE: 12 JULY 2015. THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO PRESENT THE FUNCTIONAL OUTCOMES AND COMPLICATIONS AFTER PRIMARY REPAIR OF TRICEPS TENDON RUPTURES (TTR). FROM JANUARY 2009 TO JANUARY 2013, THERE WERE 8 PATIENTS (6 MALES AND 2 FEMALES) WHO UNDERWENT TRANSOSSEOUS SUTURE REPAIR FOR TTR. THE MEAN AGE OF THE PATIENTS WAS 25.1 YEARS (RANGE 16¿42). THE TENDON RUPTURE WAS IDENTIFIED, HEMATOMA WAS EVACUATED, AND THE WOUND WAS RINSED WITH SALINE. THE ULNAR NERVE WAS IDENTIFIED AND PROTECTED BUT NOT DISSECTED DOWN TO THE ULNAR TUNNEL. ONCE THE TENDON WAS EXPOSED, KRAKOW STITCHES WERE PLACED FROM DISTAL TO PROXIMAL AND THEN BROUGHT FROM PROXIMAL TO DISTAL ON BOTH SIDES OF THE TENDON USING NO. 5 NON-ABSORBABLE SUTURE (ETHIBOND, ETHICON). THE SUBCUTANEOUS TISSUES AND SKIN WERE CLOSED PROPERLY, AND THE PATIENT WAS PLACED IN AN ABOVE-THE-ELBOW PLASTER CAST AT 90¿100 DEGREES OF ELBOW FLEXION. ULNAR NERVE ENTRAPMENT, CONFIRMED WITH EMG, OCCURRED IN ONE PATIENT (CASE# 3: (B)(6), F WHO HAD SIMPLE FALL ON OUTSTRETCHED HAND), SO ULNAR NERVE RELEASE AND ANTERIOR TRANSPOSITION WERE APPLIED 3 MONTHS AFTER SURGERY. POSTERIOR INTEROSSEOUS NERVE PALSY OCCURRED IN ONE PATIENT (CASE #6: (B)(6), M WHO HAD A MOTORCYCLE ACCIDENT AND HAD RADIAL HEAD FRACTURES) WHO UNDERWENT SIMULTANEOUS RADIAL HEAD FRACTURE FIXATION, BUT EVENTUALLY RETURNED BACK TO NORMAL 3 MONTHS POSTOPERATIVELY. ALL PATIENTS RETURNED TO THEIR PREVIOUS LEVEL OF ACTIVITY AND OCCUPATION. IN CONCLUSION, SURGICAL TREATMENT OF COMPLETE DISTAL TTR USING TRANSOSSEOUS SUTURE (TOS) TECHNIQUE IS A SAFE AND EFFECTIVE METHOD WITH MINOR COMPLICATIONS AND EXCELLENT FUNCTIONAL OUTCOMES. PHYSICIANS SHOULD BE ALERT FOR A POSSIBLE INJURY OF TRICEPS TENDON IN ALL PATIENTS WHO PRESENT IN ED AFTER A FALL ONTO THE OUTSTRETCHED HAND. THE GAP SIGN AND THE INABILITY TO EXTEND THE ELBOW ARE STRONG PHYSICAL EXAMINATION SIGNS WHICH SUGGEST TT RUPTURE, AND A SIMPLE ELBOW RADIOGRAPH SHOWING THE FLECK SIGN IS PATHOGNOMONIC FOR TT RUPTURE. IN CASE OF SUSPICIOUS CLINICAL FINDINGS, USG AND MRI CAN BE PERFORMED TO CONFIRM THE DIAGNOSIS. FURTHER WELL-DESIGNED RANDOMIZED CLINICAL TRIALS ARE NECESSARY TO OBTAIN EVIDENCE BASED KNOWLEDGE ON THE TREATMENT OF TTR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 612202 | ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN | SUTURE, NONABSORBABLE, SYNTHETIC | GAT | ETHICON INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |