MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC K-WIRE ATTACHMENT FOR PEN DRIVE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number	05.001.037
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).Device history record review: a device history review was performed and no non-conformances were detected related to the reported condition.Device evaluation: the actual device was returned for evaluation.The device was evaluated, and the reported condition was confirmed.A visual and functional assessment was performed on the device which determined that the device failed for check sleeve for spring tick¿ pass¿ if hexagon end-round sleeve and functional test check- release k-wire when pressure was applied.During service/repair, it was determined that the pinion cage complete shaft had broken off and the ball bearing was corroded.It was determined that the issues were consistent with improper cleaning and normal wear.The assignable root causes were determined to be due to normal wear out from use and user improper cleaning methods.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Event or Problem Description
It was reported from (b)(6) that the k-wire attachment device was not holding the wires while being used together with the drill/burr attachment device, which was also not holding the cutter device.During in-house engineering evaluation, it was observed that the pinion cage complete shaft had broken off.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: K-WIRE ATTACHMENT FOR PEN DRIVE
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8325877
• Report Number: 8030965-2019-60806
• Device Sequence Number: 1788819
• Product Code: HWE
• UDI-Device Identifier: 07611819167872
• UDI-Public: 7611819167872
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K043310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/23/2018

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: 05.001.037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 02/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1