MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CERCLAGE PASSER, DIVIDABLE FORCEPS, SMALL; MISC ORTHO SURGICAL INSTR

Catalog Number	03.221.010
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional 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 on june 29, 2020 that on an unknown date the two tips of the cerclage passer dividable forceps were bent and could not fit together.The surgery was successfully completed with another instrument.There was a surgical delay of ten (10) minutes.There was no consequence to patient.This complaint involves one (1) device.This report is for one (1) cerclage passer, dividable forceps, small.This is report 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 site: cq zuchwil.Selected flow: 2.Device interaction/functional.Visual inspection visual inspection confirmed that the tips of the cerclage passer do not fit together anymore, furthermore one tube is deformed.Functional test the complaint condition could be replicated and is confirmed; the tips of the cerclage passer do not properly align when in closed position.Dimensional inspection: the relevant dimensions of the tube could not be checked due to the damage incurred.However, dimensional inspection and functional test were performed per 100% at the time of manufacturing with no non-conformities documented.Document/specification review: the manufacturing review shows that the production procedures were according to the specifications and there were no issues that would contribute to this complaint condition.This instrument is made of stainless steel (1.4021 hardened and tempered) according to the hardness test certificate the correct material was used, and the hardness parameters were within the specification.Summary: the complaint condition is confirmed as one of the tubes is deformed and the instrument does not close properly anymore.The review of the production history revealed that this instrument was manufactured in february 2018 according to the specifications with a lot size of 25 pieces.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.No manufacturing related issues that would have contributed to this complaint were found.Furthermore, these instruments are function checked per 100% before they leave the manufacturing site.Based on these findings we have to assume that too much force was applied while inserting the cerclage passer, which finally caused the deformation of the tube.In this regard we would like to point out that further information / precaution hints can be found in the respective surgical technique , which note: to prevent damage do not apply too much force while inserting the cerclage passer.Deformation of the tubes can result in non-closure of the instrument when connecting the halves.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot part: 03.221.010, lot: l604625, manufacturing site: umkirch, release to warehouse date: feb.28, 2018.A manufacturing record evaluation was performed for the finished device lot number, 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: CERCLAGE PASSER, DIVIDABLE FORCEPS, SMALL
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10283209
• Report Number: 8030965-2020-04890
• Device Sequence Number: 515468
• Product Code: LXH
• UDI-Device Identifier: 07611819880092
• UDI-Public: (01)07611819880092
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2020

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: 03.221.010
• Device Lot Number: L604625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 08/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1