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

Catalog Number 530.715

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The serial number was unknown.Therefore, 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 knee arthoplasty (tka) surgical procedure, it was discovered that the battery reciprocator device suddenly stopped when the bone cutting was about 80 percent completed.It was reported that the surgeon replaced the battery device; however, the device could not work at all.There were no delays to the surgical procedure as the surgery was completed by using a chisel.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.

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 confirmed.It was further determined that the device failed pretest for functional test, check trigger and electronic control unit (ecu), function and check oscillation frequency.After the pre-test, the device was disassembled, ecu and motor were measured separately, and it was observed that the ecu was defective.During the test, it was determined that there were electrical interruptions until the absolute deadlock were experienced.It was determined that the reported malfunction was attributed to the ecu.It was further determined that the control unit was not functioning and was defective.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.

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.Serial number: the device serial number was unknown in the initial report; therefore, the device manufacture date was also unknown.Upon receipt of the device, the serial number was identified as (b)(4).The udi has been updated accordingly.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.

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.Device was used for treatment, not diagnosis.Mfr site: the manufacturer location was documented as unknown the initial medwatch report.The location has been updated to oberdorf.Contact office name/address have been updated accordingly to reflect the corrected manufacturing facility.It was documented in the initial medwatch report that the date of manufacture (dom) was unknown.The dom (feb 4, 2016) has been updated to reflect the date the device was manufactured.The unique identifier( udi) has been updated accordingly.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: BATTERY RECIPROCATOR II FOR BPL II
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf ; SZ
• MDR Report Key: 7633727
• MDR Text Key: 112171078
• Report Number: 8030965-2018-54568
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 7611819491854
• UDI-Public: (01)7611819491854
• 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,Followup
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.715
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Date Manufacturer Received: 09/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BATTERY DEVICE; BATTERY DEVICE