MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC CHUCK WITH KEY-REAM SPEED F/BPL; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number	530.732
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device was running untrue (wobbling).A visual and functional assessment was performed which found that the device failed for (check cannulation) due to a broken coupling shaft and (check the untrue running) as the device was wobbly.During repair, it was observed that the coupling shaft was broken and the bearings were worn.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to normal wear.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that during a surgical procedure on a fractured hip, it was observed that chuck attachment device was wobbling.There were no delays to the surgical procedure as a spare device was available to complete the surgery.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: CHUCK WITH KEY-REAM SPEED F/BPL
• 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: 7098875
• Report Number: 8030965-2017-50264
• Device Sequence Number: 16511404
• Product Code: HWE
• UDI-Device Identifier: 07611819802629
• UDI-Public: (01)07611819802629(11)130912(10)8543926
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/13/2017

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: 530.732
• Device Lot Number: 8543926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Initial Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1