MAUDE Adverse Event Report: SYNTHES GMBH SYNMESH IMPLANT HOLDER SMALL/STRAIGHT; MISC ORTHO SURGICAL INSTR

Catalog Number	396.391
Medical Device Problem Codes	Compatibility Problem (2960); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2021
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 that on (b)(6) 2021, the patient underwent for a revision surgery due to infection.During the surgery, the surgeon removed the cage and used the synmesh for interbody fusion.The synmesh had been deformed.There was 60-minutes surgical delay.The patient status was unknown.No further information is available.Concomitant device reported: unk - impaction inst: hammer/mallet: (part# unknown; lot# unknown; quantity: unknown).This complaint involves three (3) devices.This report is for (1) synmesh® implant holder small/straight.This report is 1 of 1 for (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.Investigation summary: the product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that synmesh impl-holder sm straig sst one of the jaws of the device was bent and no other issues were identified.The dimensional inspection was not performed due to the post manufacturing damage.Functional test cannot be performed since the device was returned by itself but the alleged unable to assemble condition can be confirmed since the jaw was bent might be the reason for the complaint condition.The observed condition of synmesh impl-holder sm straig sst in the device was 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 confirmed for synmesh impl-holder sm straig sst.While no definitive root cause could be determined, there is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.There was no indication that a design or manufacturing issue contributed to the complaint.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.Device history lot: part: 396.391, lot: a7bb39, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 01 october 2018.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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: SYNMESH IMPLANT HOLDER SMALL/STRAIGHT
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12447630
• Report Number: 8030965-2021-07604
• Device Sequence Number: 3503731
• Product Code: LXH
• UDI-Device Identifier: 07611819744431
• UDI-Public: (01)07611819744431
• 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: foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021

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: 396.391
• Device Lot Number: A7BB39
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 10/18/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SYNMESH Ø12 H88 TI; SYNMESH Ø12 H88 TI; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: SPINE; SYNMESH Ø12 H88 TI; SYNMESH Ø12 H88 TI; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: SPINE