MAUDE Adverse Event Report: SYNTHES GMBH CERCLAGE PASSER, DIVIDABLE FORCEPS, LARGE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.221.011
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2021
Type of Reportable Event	Malfunction
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 instrument would not line up and there was difficulty getting the wire to pass through.This report involves one (1) cerclage passer, dividable forceps, large.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Reporter is a synthes employee.Part # 03.221.011, lot # l273778.Manufacturing date: april 4, 2017.A dhr review was performed for the finished device lot number and the production was according to the requirements and no non-conformance was identified within dhr.The inspection sheet showed the evidence for the functional test with a trokar and a wire ø1,5 and all parts of the lot have passed the tests.Additionally, every 5th part was functional tested with a wire ø1,25 and all parts tested have passed the test.Photo investigation: a photo-investigation was performed on the image.Upon inspecting the image provided, it could not be confirmed if the tubes allow for clear passage of the wire through it.The complaint is not confirmed based on the image provided.Visual inspection: the cercl-passer ø60 min-invasive (part #: 03.221.011, lot #: l273778) was received at us customer quality (cq).Visual inspection of the complaint device showed that both opened tips which allow the cable to pass through were deformed.Both tips did not align when in closed position.Functional test: a functional assessment was not performed with the complaint device since the cable was not returned and also due to the damage of the device.Can the complaint be replicated with the returned device? unable to perform.Dimensional inspection: no dimensional inspection was performed due to the nature of the defect.Document/specification review: current and manufactured revisions were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as both opened tips which allow the cable to pass through were deformed.This condition caused the misalignment and the assembling issues reported.No root cause could definitively be determined for the reported complaint condition.No new, unique, or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: CERCLAGE PASSER, DIVIDABLE FORCEPS, LARGE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12414494
• Report Number: 8030965-2021-07430
• Device Sequence Number: 19733480
• Product Code: LXH
• UDI-Device Identifier: 07611819880108
• UDI-Public: (01)07611819880108
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/14/2021

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: 03.221.011
• Device Lot Number: L273778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 09/02/2021
• 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: UNK - CABLE/WIRE