MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC BATTERY REAMER/DRILL FOR BPL II; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 530.705

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/21/2018

Event Type  malfunction  

Manufacturer Narrative

Reporter¿s complete address was not provided.The manufacturing location was unknown.The serial number was unknown.Therefore, the device manufacture date is unknown.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported from (b)(6) that during a total hip arthroplasty (tha) surgical procedure, it was discovered that the battery reamer/drill device stopped operating.There was a forty-minute delay to the surgical procedure.The surgery was completed with a spare device.There was patient involvement reported.It was not reported if there were any 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.

Manufacturer Narrative

Additional information and correction: device investigation update: h6: upon further investigation of the device, it was determined that the turning knob on the oscillation started to unscrew by itself.It was further determined that the control unit was not functioning and was defective.It was further determined that, although normal wear was initially determined as the root cause, the defective electronic control unit (ecu) of the anodizing on the housing suggested that the device was improperly reprocessed.Therefore, the assignable root cause was determined to be due to improper reprocessing, which is user error, misuse, and / or abuse.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The serial number was documented as unknown in the initial report and has been updated as (b)(4).The udi has been updated accordingly.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.It was further determined that the device failed pretest for functional test.After the pre-test, the device was disassembled and the electronic control unit (ecu) and the motor where measured separately.It was determined that the ecu had no function and the anodizing on the electronic control unit (ecu) was discolored.The assignable root cause was determined to be due wear from normal use servicing.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: BATTERY REAMER/DRILL FOR BPL II
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7561776
• MDR Text Key: 109839197
• Report Number: 8030965-2018-54091
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 7611819491830
• UDI-Public: (01)7611819491830
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.705
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Date Manufacturer Received: 07/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1