MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC DRILL BIT Ø4 W/CENTER-TIP L148/122 3FLUT; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number	511.417
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history record review: a device history review was performed and no non-conformance's were detected related to the reported condition.Device evaluation: the actual device was returned for evaluation.Quality engineering evaluated the device and it was determined that the device passed all the inspection criteria during the pre-repair diagnostic assessment.During assessment , it was observed that the plastic shaft of the drill bit was damaged.It was further observed that the plastic shaft had melted during milling, resulting in the smoke coming out of the device while operating.It was determined that fused traces of plastics were deposited on the coupling side of the drill bit.It was determined that the drill bit was blunt, therefore, it was not possible to drill anymore.It was further determined that the drill was heavily blunt.It was determined that the drill was wrongly operated.It was determined that improper handling was the cause for the failure to occur.The assignable root cause was determined to be traced to user, which is user error/ improper handling.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Event or Problem Description
It was reported by (b)(6) that at the time of milling, smoke began to come out of the mark on the drill bit device.It was further reported that the device had marks of melted plastic due to heat.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.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: DRILL BIT Ø4 W/CENTER-TIP L148/122 3FLUT
• 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: 9452931
• Report Number: 8030965-2019-70576
• Device Sequence Number: 2089951
• Product Code: HWE
• UDI-Device Identifier: 07611819036376
• UDI-Public: 07611819036376
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/22/2019

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: 511.417
• Device Lot Number: U219982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1