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

Catalog Number	05.001.254
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Not Applicable (3189)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi ¿ (b)(4).
Event or Problem Description
It was reported that one of the three ¿teeth¿ located in the large chuck with key device that hold the pin devices in place had fallen out of the chuck device.It was not reported if the event occurred during a surgical procedure.It was not reported if there was a delay to a planned procedure.It was not reported if there was a spare device available for use.There was no human patient involvement as this device is intended for veterinary use only.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was not reported.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Additional Manufacturer Narrative
The device serial number ((b)(4)) was inadvertently documented as the lot number in the initial report.The serial number has been updated accordingly.The udi has also been updated accordingly.If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi ¿ (b)(4).
Additional Manufacturer Narrative
Additional narrative: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the one of the teeth came out of the chuck device.It was further determined that the device failed pretest for general condition, drill chuck, and function of the tool coupling.Therefore, the reported condition that one of the three ¿teeth¿ located in the large chuck with key device was missing was confirmed.The assignable root cause was determined to be traced to component failure.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: LARGE CHUCK WITH KEY REAMING SPEED
• 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: 9208636
• Report Number: 8030965-2019-69442
• Device Sequence Number: 13564702
• Product Code: HWE
• UDI-Device Identifier: 07611819979741
• UDI-Public: 7611819979741
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup,Followup
• Report Date (Section B): 10/02/2019

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: 05.001.254
• Device Lot Number: 1622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 10/27/2019; 11/05/2019
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 10/30/2019; 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1