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
Device history records review was completed for part: 03.221.010, lot: 8812052.Manufacturing location: (b)(4) , release to warehouse date: may 13, 2014.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.Product investigation was completed.Visual inspection confirmed that the tips of the cerclage passer do not properly align when in closed position, furthermore one tube is slightly deformed.The complaint condition could be replicated and is confirmed; the tips of the cerclage passer do not properly align when in closed position.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-conformity documented.The investigation confirmed that the damage of the tube is determined to be post-production/acceptance criteria, therefore no drawing/specification review is needed.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 may 2014 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.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 of 45-49 hrc.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.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 on an unknown date, the proper closing and locking of cerclage passer was impossible in a closed position.It was unknown if there was patient or procedure involvement.This report is for one (1) cerclage passer.This is report 1 of 1 for (b)(4).

• 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: 8616748
• Report Number: 8030965-2019-64032
• Device Sequence Number: 19335559
• Product Code: LXH
• UDI-Device Identifier: 07611819880092
• UDI-Public: (01)07611819880092
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 02/21/2019

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: 03.221.010
• Device Lot Number: 8812052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 05/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1