MAUDE Adverse Event Report: SYNTHES GMBH DRIVING CAP WITH HANDLE ADAPTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.010.047
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a synthes employee.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 that after the surgery when trying to dismantle the connector from the insertion handle, they were stuck together.When the combination wrench was used, it broke.This report is for one (1) driving cap with handle adapter.This is report 2 of 3 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.H3, h6: investigation summary investigation site: cq zuchwil.Selected flow: device interaction/functional.Visual inspection: the visual inspection has shown that the connector is strongly jammed with the insertion handle.The article is in a used condition.The slider arms are bent outward and there are many marks from hammer blows on top of the device visible.Functional test: the parts could not be separated, consequently an accurate functional test could not be performed.Further attempts with other mechanical instruments failed to release the jammed connector from the insertion handle.Drawing/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.The investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage.Summary: the received condition of the device is concordant with the complaint description and the complaint condition is confirmed.The investigation has shown that the connector is completely jammed at the insertion handle.These indications led us assume that the device encountered unintended forces, such as a mechanical overload during surgery, which finally caused the post manufacturing damages.One of the reason for this occurrence may have been insufficient tighten to the insertion handle.If the connection is not tight enough, the forces while hammering may cause the damage of the thread at the connector.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.The root cause was identified during the performed cq evaluation and therefore the in the investigation flow listed remaining investigation steps "dimensional inspection:" are not required.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Device history lot part: 03.010.047, lot: 8741855 , manufacturing site: hägendorf, release to warehouse date: january 29, 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.

• Brand Name: DRIVING CAP WITH HANDLE ADAPTER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11193890
• Report Number: 8030965-2021-00379
• Device Sequence Number: 14388912
• Product Code: LXH
• UDI-Device Identifier: 07611819760844
• UDI-Public: 07611819760844
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2020

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: 03.010.047
• Device Lot Number: 8741855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Initial Date Received by Manufacturer: 12/23/2020
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1