SUREGRIP SOFT TISSUE RONGEUR
Report
- Report Number
- 1833053-2022-00005
- Event Type
- Malfunction
- Date Received
- December 27, 2022
- Date of Event
- November 21, 2022
- Report Date
- April 14, 2023
- Manufacturer
- INNOMED INC.
- Product Code
- HTC
- UDI-DI
- 00840277105943
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
REPORT MW5113547 WAS RECEIVED AT INNOMED, INC FROM THE CENTER FOR DEVICES AND RADIOLOGICAL HEALTH ON 12/12/2022 WITH THE EVENT DESCRIPTION DOCUMENTED IN DESCRIBE EVENT OR PROBLEM. INNOMED CONTACTED THE INITIAL REPORTER VIA EMAIL ON THE DAY THE DEVICE WAS RECEIVED AND REQUESTED TO HAVE IT RETURNED TO EVALUATE THE DESCRIBED CONDITION. INNOMED WILL FOLLOW UP WHEN THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION HAS BEEN COMPLETED.
THE AFFECTED DEVICE WAS NEVER RETURNED TO INNOMED FOR EVALUATION BY THE INITIAL REPORTER. INNOMED SURVEYED THE CAPA AND COMPLAINTS DATABASE FOR THIS PART AND THE DESCRIBED ISSUE. NO CAPAS WERE ISSUED. THREE COMPLAINTS WERE IDENTIFIED IN THE INTERNAL COMPLAINTS DATABASE WITH THIS ISSUE. IN THE FIRST COMPLAINT, AN INVESTIGATION AND A 5 WHY WERE PERFORMED TO DETERMINE THE ROOT CAUSE. BASED ON THE DETERMINED ROOT CAUSE, THE CORRECTION INCLUDED CHANGING FROM LASER WELDING TO STICK WELDING. THE LATTER WAS DETERMINED TO BE THE MORE APPROPRIATE WELD, AS IT ENSURED THE BEST FIT NEEDED TO KEEP THE PIN INTAKE AND IMMOBILE. THIS INFORMATION WAS DOCUMENTED IN CA# 249. ALSO DOCUMENTED WERE CONTAINMENT ACTIVITIES, AND PREVENTIVE MEASURES. IT WAS DETERMINED THAT THE DEVICE IN THE SECOND COMPLAINT HAD THE SAME LOT NUMBER AS THE DEVICE IN FIRST COMPLAINT. THEREFORE, IT WAS NOT A REPEAT ISSUE AFTER CORRECTION WAS IMPLEMENTED. THE AFOREMENTIONED COMPLAINTS WERE RECEIVED AT INNOMED IN 2014 AND 2015. IN THE THIRD COMPLAINT, THE CUSTOMER NEVER RETURNED THE DEVICE TO INNOMED FOR INSPECTION AND EVALUATION. INNOMED DETERMINED THAT THE DESCRIBED ISSUE OCCURED AFTER THE CORRECTIVE MEASURE WAS IMPLEMENTED. THE COMPLAINT WAS RECEIVED IN 2022. INNOMED HAS NOT RECEIVED A COMPLAINT REGARDING THIS DEVICE AND ITS DESCRIBED ISSUE IN ALMOST NINE (9) YEARS. INNOMED ALSO WAS UNABLE TO DETERMINE IF THE LAST COMPLAINT WAS USER INDUCED. THIS PART WILL BE MONITORED TO DETERMINED IF ADDITIONAL CORRECTIVE MEASURES ARE REQUIRED.
PT. HAD REVERSE TOTAL SHOULDER SURGERY. SURGERY WAS COMPLETED AND PATIENT TAKEN TO PACU. THE INSTRUMENTS FOR THE CASE WAS TAKEN TO DECONTAMINATION, WHERE THE SPD EMPLOYEE WASHING THE INSTRUMENT NOTICED A PIECE MISSING FROM A PITUITARY RONGEUR. PHYSICIAN RESPONDED THAT HE SAW THE X-RAY AND THE PIECE OF METAL. NOTED SHOULDN'T BE A PROBLEM NOW. HE PLANS TO RE X-RAY AT HIS POST APPOINTMENT TO SEE IF THE PIECE HAD MOVED WHICH WAS DETERMINED TO BE A PIECE OF THE PITUITARY RONGEUR. THE PATIENT WAS SENT HOME, AND IT APPEARS THE SMALL PIECE LEFT IN THE SHOULDER SHOULD NOT BE PROBLEM, BUT WILL BE MONITORED ON FUTURE APPOINTMENTS.
PT. HAD REVERSE TOTAL SHOULDER SURGERY. SURGERY WAS COMPLETED AND PATIENT TAKEN TO PACU. THE INSTRUMENTS FOR THE CASE WAS TAKEN TO DECONTAMINATION, WHERE THE SPD EMPLOYEE WASHING THE INSTRUMENT NOTICED A PIECE MISSING FROM A PITUITARY RONGEUR. PHYSICIAN RESPONDED THAT HE SAW THE X-RAY AND THE PIECE OF METAL. NOTED SHOULDN'T BE A PROBLEM NOW. HE PLANS TO RE X-RAY AT HIS POST APPOINTMENT TO SEE IF THE PIECE HAD MOVED WHICH WAS DETERMINED TO BE A PIECE OF THE PITUITARY RONGEUR. THE PATIENT WAS SENT HOME, AND IT APPEARS THE SMALL PIECE LEFT IN THE SHOULDER SHOULD NOT BE PROBLEM, BUT WILL BE MONITORED ON FUTURE APPOINTMENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2725615 | SUREGRIP SOFT TISSUE RONGEUR | PLIERS | HTC | INNOMED INC. | 3645-02 | 00840277105943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |