MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC LID FOR BATTERY HANDPIECE MODULAR, TRS; BATTERY, REPLACEMENT, RECHARGEABLE

Catalog Number	05.001.227
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, the condition was confirmed.The assignable root cause was traced to improper maintenance.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Event or Problem Description
It was reported from (b)(6) that during pre-testing, it was observed that the lid device had a lid leak tightness failure and caused the hand piece to run in the locked position.The device also failed pretest for check the function with power module and handpiece and check for leakage.The event was not related to surgery.There were no reports of injuries, medical intervention or prolonged hospitalization.The date of event was unknown but was known to have occurred in 2019.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: LID FOR BATTERY HANDPIECE MODULAR, TRS
• Common Device Name: BATTERY, REPLACEMENT, RECHARGEABLE
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9291958
• Report Number: 8030965-2019-70042
• Device Sequence Number: 19333732
• Product Code: MOQ
• UDI-Device Identifier: 10886982130099
• UDI-Public: 10886982130099
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 10/14/2019

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: 05.001.227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 11/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1