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

Catalog Number	03.221.011
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a synthes employee.Part: 03.221.011, lot: l551682.Manufacturing site: (b)(4).Release to warehouse date: november 23, 2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.Visual inspection: visual inspection confirmed that the tips of the cerclage passer do not properly align when in closed position, 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 investigation confirmed that the damage of the tube is determined to be post-production/acceptance criteria's, therefore no drawing/specification review is needed.Summary: the complaint condition is confirmed as one of the tubes is deformed and the instrument does not close properly.The review of the production history revealed that this instrument was manufactured in november 2017 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.This instrument is made of (b)(4).According to the hardness test certificate the correct material was used, and the hardness parameters were within the specification.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.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 (b)(6) reports an event as follows: it was reported that during maintenance on march 25, 2019, it was discovered that two parts of the cerclage passer would not go together.There was no patient involvement.Upon manufacturer receipt and investigation, it was determined that the device was deformed/bent.This report is for a cerclage passer, dividable forceps, large.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.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: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8691844
• Report Number: 8030965-2019-65210
• Device Sequence Number: 1941424
• Product Code: LXH
• UDI-Device Identifier: 07611819880108
• UDI-Public: (01)07611819880108
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2019

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: L551682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 06/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1