MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH JOINT PREP/CARTILAGE REMOVER 20 DEG BEND/12MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.111.014
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: initial reporter is synthes sales representative.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.
Event or Problem Description
Device report from synthes reports an event in united kingdom as follows: it was reported that on an unknown date, the joint prep/cartilage remover broke during an unknown procedure.No further information was provided.This report is for one (1) joint prep/cartilage remover 20 deg bend/12mm.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 summary: investigation site: customer quality (cq) zuchwil selected flow: damaged.Visual inspection: the received device is broken apart at the shaft.Furthermore, there are several mechanical damages visible on the surface.All features related to the reported complaint condition were reviewed and no other issues were identified.Dimensional inspection: a dimensional test is not appropriate, since all complaint-relevant dimensions can no longer correspond to the valid technical drawings specifications due to the damage incurred.Drawing/specification review: the manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Furthermore, as indicated in the manufacturing documents, the correct material (1.4021) was used according iso 7153-1 and that the hardness was within the specification.Summary: the complaint condition is confirmed as the device was found broken.Because of the damage, it is not possible to measure the relevant dimensions anymore.However, based on the findings above no fault could be found in material or during the production.We suppose that a mechanical overload situation during use could lead to reported complaint condition.Finally, we conclude that no product design or manufacturing issues were observed that may have contributed to the complaint condition.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: 03.111.014, lot: 1474764, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: september 25, 2014.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.
Event or Problem Description
It was reported that on (b)(6) 2020, the joint prep/cartilage remover broke during an open reduction and internal fixation (orif) calcaneal fracture procedure.Fragments were generated and removed easily without additional intervention.The procedure was successfully completed with no surgical delay.

• Brand Name: JOINT PREP/CARTILAGE REMOVER 20 DEG BEND/12MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10344023
• Report Number: 8030965-2020-05446
• Device Sequence Number: 16344689
• Product Code: LXH
• UDI-Device Identifier: 07611819373341
• UDI-Public: (01)07611819373341
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2020

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: 03.111.014
• Device Lot Number: 1474764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 08/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1