MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC BATTERY CASING FOR BATTERY POWER LINE II; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number	530.690
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
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
The reporter¿s complete address and phone number was not provided.The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
This is report 2 of 2 for the same event: it was reported from (b)(6) that during a knee osteoarthritis (left side) surgical procedure, it was discovered that the battery reamer/drill device suddenly stopped working when used together with the battery casing device.It was reported that the event occurred during use on a patient.There was a twenty minute delay to the surgical procedure.It was not reported if a spare device was available.There was patient involvement reported.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.
Additional Manufacturer Narrative
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 not confirmed.A functional assessment was performed and the device met all technical requirements and no failures were identified.Therefore, an assignable root cause was not determined.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: BATTERY CASING FOR BATTERY POWER LINE II
• Common Device Name: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7139985
• Report Number: 8030965-2017-50470
• Device Sequence Number: 1290397
• Product Code: GEY
• UDI-Device Identifier: 07611819491823
• UDI-Public: (01)07611819491823(11)160519
• Combination Product (Y/N): N
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2017

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: 530.690
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 12/12/2017
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 01/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1