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 Codes	Unintended System Motion (1430); Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to improper maintenance, which is user error, misuse, and / or abuse.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 during service and evaluation, it was determined that the lid device was leaky.It was further determined that the device failed pretest for check for leakage and check function ¿lock/unlock¿ with safety pin.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should available, a supplemental medwatch will be submitted accordingly.
Additional Manufacturer Narrative
Additional information: device evaluation update: upon further review of the device investigation, it was determined that in addition to the pretest failures stated in the initial report, the device also failed pretest for check the locking function with hand piece.This information was inadvertently missed in the initial report.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: 7268379
• Report Number: 8030965-2018-51087
• Device Sequence Number: 1475179
• Product Code: MOQ
• UDI-Device Identifier: 07611819978041
• UDI-Public: (01)07611819978041(11)130906
• 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,Followup
• Report Date (Section B): 12/06/2017

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2017
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 02/13/2018
• Initial Report FDA Received Date: 02/13/2018
• Supplement Report FDA Received Date: 02/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1