MAUDE Adverse Event Report: SYNTHES GMBH THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS; MISC ORTHO SURGICAL INSTR

Catalog Number	03.614.017
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported on (b)(6) 2021, the patient underwent for a surgery.During the surgery, the surgeon was not able to connect the screwdriver to a screw.Also, ratchet movement on the ratchet handle became awkward.The surgery completed with 30-minutes delay.The patient outcome was unknown.Concomitant device reported: unknown screw (part # unknown; lot # unknown; quantity: 1).This complaint involves three (3) devices.This report is for (1)threaded holding sleeve for polyaxial screws.This report is 2 of 2 (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6: part: 03.614.017, lot: t149639, manufacturing site: tuttlingen, release to warehouse date: march 14, 2017.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The product was returned to us customer quality (cq) for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that hold-sl have slight scratches on the devices and no other issues were identified.The dimensional inspection was not performed for hold-sl due to alleged complaint condition.The functional test was performed with the received mating device hexagonal screwdriver shaft cross pinned the device was able to assemble and functioning as intended.The observed unable to assemble condition of the components is not consistent with the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for hold-sl.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Drawing/specifications reviewed the following drawing reflecting the current and manufacture revision was reviewed: spring loaded threaded driver sleeve 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.

• Brand Name: THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11867181
• Report Number: 8030965-2021-04156
• Device Sequence Number: 17074953
• Product Code: LXH
• UDI-Device Identifier: 07611819968417
• UDI-Public: 07611819968417
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.614.017
• Device Lot Number: T149639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 09/08/2021; 09/08/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 09/08/2021; 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HANDLE W/RATCHET WRENCH F/QC SM; HEXAGONAL SCREWDRIVER SHAFT CROSS PINNED; UNK - SCREWS