SYMMETRY SURGICAL INC.
Report
- Report Number
- 3007208013-2024-00017
- Event Type
- Malfunction
- Date Received
- May 8, 2024
- Report Date
- June 24, 2024
- Manufacturer
- SYMMETRY SURGICAL INC.
- Product Code
- HTX
- UDI-DI
- 00887482093313
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
AWAITING ADDITIONAL INFORMATION AND/OR RETURN OF THE REPORTED DEVICE TO COMPLETE THE EVALUATION.
RECEIVED VIA VOLUNTARY MW5153291. THE CUSTOMER PROVIDED A PICTURE WHICH CONFIRMED THAT THE SCREW TO THE SLIDING SHAFT HAD FALLEN OUT OF THE DEVICE. THE DEVICE WAS RETURNED AND EVALUATED. THE DEVICE WAS CONFIRMED TO HAVE SIGNIFICANT WEAR AND TEAR. WE WERE ABLE TO CONFIRM THAT THE LOT NUMBER IS NOT VISIBLE ON THE DEVICE. BASED ON THE APPEARANCE OF THE DEVICE THE DEVICE HAS SIGNIFICANT WEAR AND TEAR. THE CUSTOMER ORDER HISTORY WAS REVIEWED, THE ONLY PURCHASE FOR THIS PRODUCT CODE WAS IN (B)(6) 2017. AS A RESULT, IT IS LIKELY THAT THE DEVICE HAD BEEN IN USE FOR APPROXIMATELY 7 YEARS PRIOR TO THE ISSUE OCCURRING. ROOT CAUSE: WEAR AND TEAR OVER MANY YEARS OF USE. IF ADDITIONAL INFORMATION IS OBTAINED THAT IS PERTINENT TO THE INVESTIGATION OR PROVIDES ADDITIONAL DETAILS A FOLLOW-UP REPORT WILL BE PROVIDED. UNTIL SUCH TIME, THIS CAN BE SEEN AS THE FINAL REPORT.
RECEIVED VIA VOLUNTARY MW5153291 " KERRISON RONGEUR BROKE WHILE IN USE, A PIN THAT HOLDS TOGETHER MULTIPLE PIECES CAME OUT. ALL PIECES RETRIEVED.
RECEIVED VIA VOLUNTARY MW5153291 " KERRISON RONGEUR BROKE WHILE IN USE, A PIN THAT HOLDS TOGETHER MULTIPLE PIECES CAME OUT. ALL PIECES RETRIEVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1357935 | SYMMETRY SURGICAL INC. | RONGEUR | HTX | SYMMETRY SURGICAL INC. | 57-0763 | 00887482093313 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |