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 Consequences Or Impact To Patient (2199)

Event Date 05/14/2018

Event Type  malfunction  

Manufacturer Narrative

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 the battery reamer/drill device was not working anymore.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available.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.

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.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 determined that the control unit was not functioning and was defective.It was further determined that the control was defective.It was further determined that the device failed pretest for: function test ¿ forward ¿ and ¿ reverse ¿, check trigger and ecu (electric control unit) function and functional test.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.

• 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: 7560404
• MDR Text Key: 109770423
• Report Number: 8030965-2018-54078
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 7611819491830
• UDI-Public: (01)7611819491830(11)150709
• 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
• Report Date: 05/18/2018

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
• 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: 06/28/2018
• Initial Date Manufacturer Received: 05/18/2018
• Initial Date FDA Received: 06/01/2018
• Supplement Dates Manufacturer Received: 06/29/2018
• Supplement Dates FDA Received: 07/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1