MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 10.5CM LONG ATTACHMENT; MOTOR, DRILL, ELECTRIC - ATTACHMENT

Model Number	LONG-S
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to component failure from maintenance deficiency.Udi: (b)(4).
Event or Problem Description
It was reported that the attachment device was broken and the drill devices are not lining up and getting stuck inside.During service and evaluation, it was determined that the device had vibration and excessive noise, the color band was chipping/fading, and the bearing was worn.It was further reported that the device failed pre-test for visual and vibration assessments.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 the 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 this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 10.5CM LONG ATTACHMENT
• Common Device Name: MOTOR, DRILL, ELECTRIC - ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10568529
• Report Number: 1045834-2020-01541
• Device Sequence Number: 14080593
• Product Code: HBC
• UDI-Device Identifier: 00845384003601
• UDI-Public: 00845384003601
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K011444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/18/2020

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 Model Number: LONG-S
• Device Catalogue Number: LONG-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 09/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1