MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 13.5CM ANGLE ATTACHMENT; MOTOR, DRILL, ELECTRIC - ATTACHMENT

Catalog Number	QD14-S
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
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.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.(b)(4).
Event or Problem Description
It was reported from the (b)(6) that after an unspecified surgical procedure it was observed that the attachment device was making a strange sound and heating up.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was not reported, however, it was reported that the event occurred in 2020.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H10 additional narrative: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device bearings were damaged and the cutter could not be inserted.It was further determined that the device failed pretest for cutter insertion.Therefore, the reported condition that the device was making a strange noise, and heating up was confirmed.The assignable root cause of this condition was determined to be traced to maintenance, which is user error/misuse/abuse.

• Brand Name: 13.5CM ANGLE 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: 10414263
• Report Number: 1045834-2020-01308
• Device Sequence Number: 3539119
• Product Code: HBC
• UDI-Device Identifier: 00845384006619
• UDI-Public: 845384006619
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K011444
• 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,Followup
• Report Date (Section B): 08/05/2020

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 Catalogue Number: QD14-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 09/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1