CLASSIC PLUS NEEDLE HOLDER, MAYO-HEGAR
Report
- Report Number
- 3007208013-2025-00027
- Event Type
- Injury
- Date Received
- July 2, 2025
- Report Date
- October 29, 2025
- Manufacturer
- SYMMETRY SURGICAL INC.
- Product Code
- HXK
- UDI-DI
- 00887482009710
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE DEVICE WAS RETURNED AND EVALUATED, AND THE COMPLAINT WAS CONFIRMED. UPON INSPECTION AND SUBSEQUENT DISCUSSIONS WITH THE SUPPLIER REGARDING THE NATURE OF THE OBSERVED FAILURE, IT WAS CONCLUDED THAT THE ROOT CAUSE WAS A SUPPLIER MANUFACTURING ISSUE. THE ISSUE WAS TRACED TO INCONSISTENCIES IN THE SOLDERING PROCESS OF THE TUNGSTEN CARBIDE INSERTS, WHICH COMPROMISED PRODUCT INTEGRITY ACROSS MULTIPLE PRODUCTION LOTS. BASED ON THE SUPPLIER'S INVESTIGATION, IT WAS DETERMINED THAT THE FAILURE IMPACTED PRODUCTION LOTS MANUFACTURED BETWEEN LATE 2024 AND MAY 2025. A DEEPER REVIEW REVEALED THAT A SPECIFIC EMPLOYEE HAD BEEN CONSISTENTLY "INVOLVED" IN THE SOLDERING TUNGSTEN CARBIDE INSERTS ACROSS THE SUSPECTED AFFECTED LOTS, EXTENDING BEYOND THOSE INITIALLY IDENTIFIED IN THIS COMPLAINT. IN RESPONSE TO THE MULTIPLE CUSTOMER COMPLAINTS OF NEEDLE HOLDER INSERTS BREAKING OFF, THE SUPPLIER HAS BEEN ISSUED A SCAR AND IS REQUESTED TO PROVIDE A DETAILED ROOT CAUSE ANALYSIS ALONG WITH A CORRECTIVE ACTION PLAN TO ADDRESS THE OBSERVED FAILURE. BASED ON THE SUPPLIER'S RECOMMENDATION, THE IDENTIFIED SUSPECT LOTS WILL BE RETURNED TO THEIR FACILITY FOR FURTHER EVALUATION. THIS SHOULD BE CONSIDERED THE FINAL REPORT. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
THE ACTUAL PART WAS RETURNED FOR EVALUATION. ADDITIONALLY, WE RECEIVED A MEDSUN REPORT WITH MORE INFORMATION AND HAVE CONFIRMED WITH TEH SUBMITTER THAT THIS REPORT IS RELATED TO THIS COMPLAINT. FROM THE MEDSUN REPORT, WE IDENTIFIED THAT THERE WAS A SERIOUS INJURY RELATED TO THIS (NEEDING MEDICAL INTERVENTION), AND HAVE UPDATED THE RELEVANT PORTIONS OF THIS REPORT. THE ROOT CAUSE IS NORMAL WEAR AND TEAR ON THE PART, REACHING ITS END OF LIFE. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
THE DEVICE IS IN PROCESS OF BEING RETURNED FOR EVALUATION, AND THE INVESTIGATION IS ONGOING. ONCE WE HAVE ADDITIONAL RELEVANT INFORMATION, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
WE RECEIVED ADDITIONAL INFORMATION ON JULY 15, 2025, VIA MEDSUN REPORT (B)(4). IT HAS BEEN CONFIRMED THAT REPORT IS THE SAME COMPLAINT. IN THIS REPORT, WE DISCOVERED THAT THERE WAS A SERIOUS INJURY. THAT REPORT STATED "A NEEDLE DRIVER WAS FOUND IN STERILE PROCESSING TO BE MISSING A LAYER OF THE INNER TIP. THE INSTRUMENT WAS PULLED FROM SERVICE. THE QUALITY ASSURANCE TEAM CONNECTED AND CONFIRMED THE RESULTS OF THE PATHOLOGY SPECIMEN, A 1 MM X 2 MM METALLIC FLAKE OF A TEXTURED GRIPPING SURFACE, TO THE SEQUESTERED NEEDLE DRIVER. THIS METAL FLECK WAS IN THE PATIENT IN THE WOUND, FOUND ON ROUTINE POST OPERATIVE XRAY, LIKELY BROKE OFF DURING SUTURING/CLOSING OF THE WOUND. THE NEEDLE DRIVER/HOLDER WS STILL FUNCTIONAL, AND THE BROKEN OFF FLECK WAS SO SMALL, IT WAS NOT IDENTIFIED AT TIME OF USE ON PATIENT. THE PATIENT DID RETURN TO THE OR FOR REMOVAL OF THE FOREIGN OBJECT."
COMPLAINANT ALLEGES "WE HAD A NEEDLE HOLDER THAT BROKE, ITS SYMMETRY 36-2017. PART OF THE CARBIDE TUNGSTEN ON THE JAW BROKE OFF. IT BROKE OFF INSIDE A PATIENT".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 170463 | CLASSIC PLUS NEEDLE HOLDER, MAYO-HEGAR | NEEDLE HOLDER | HXK | SYMMETRY SURGICAL INC. | 36-2017 | UNKNOWN | 00887482009710 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Female | Required Intervention |