MAUDE Adverse Event Report: SYNTHES GMBH MESH CUTTING SCISSORS SHORT NOSE; MISC ORTHO SURGICAL INSTR

Catalog Number	03.503.033
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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) 2020 during a fibula fixation procedure, the mesh cutting scissors and 1.1mm drill bit broke.The drill bit broke when the surgeon attempted to clean it.There was no patient impact.The procedure was successfully completed with other instruments that came in the system.This report is for one (1) mesh cutting scissors short nose.This is report 1 of 2 for (b)(4).
Event or Problem Description
Updated event description: the aforementioned fragment of the screw that had been left refers to the part of an implant.This is an initial procedure.This complaint involves three (3) devices.
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.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.
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 - background: intraoperatively at the time the dr used the.Shear broke, left marked with red tape product: 03.503.033, batch: t164109, intraoperatively, the drill breaks when cleaning it, product: 317.320, lot: f-25028.Visual inspection: the cutting scissors f/mesh-pl short (product code: 03.503.033 & lot no: t164109) was received at us cq.Upon visual inspection, it was observed that one of the handles was broken at the point of opening the edges.No other issues were identified with the returned device.Dimensional inspection: the dimensional inspection cannot be performed due to post-manufacturing damage.Furthermore, the complaint-relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review: the following drawing was reviewed: - 03_503_033 rev.G/f (current & manufactured) no design issues or discrepancies were identified.Conclusion: the overall complaint was confirmed for the received device was broken.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces during its use.No new malfunctions were observed during this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot : part number: 03.503.033, lot number: t164109, manufacturing site: tuttlingen, release to warehouse date: 07-feb-2018.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate was reviewed and the used material was according to the specification of the device.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: MESH CUTTING SCISSORS SHORT NOSE
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10638048
• Report Number: 8030965-2020-07757
• Device Sequence Number: 3650201
• Product Code: LXH
• UDI-Device Identifier: 07611819887596
• UDI-Public: (01)07611819887596
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 09/16/2020

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: 03.503.033
• Device Lot Number: T164109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 11/16/2020; 05/27/2021
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 11/25/2020; 05/27/2021
• 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: 1.1MM DRILL BIT/MINI QC WITH 12MM STOP/44.5MM; 1.1MM DRILL BIT/MINI QC WITH 12MM STOP/44.5MM