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

Model Number 530.705

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

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

Event Date 02/16/2018

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).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 an unspecified surgical procedure, it was observed that the battery reamer/drill device stopped working.It was not reported if there was a delay in the procedure due to the event.It was reported that an unspecified spare device was available for use.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 will be submitted accordingly.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: the device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.The device was evaluated and it was determined that the control unit of the battery reamer/drill device was not functioning and was defective.It was further determined that the device failed pretest for functional test.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to premature wear.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: 7370243
• MDR Text Key: 103449226
• Report Number: 8030965-2018-52413
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 10886982240125
• UDI-Public: (01)10886982240125(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: 02/28/2018

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: No Information
• Device Model Number: 530.705
• Device Catalogue Number: 530.705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Initial Date Manufacturer Received: 02/28/2018
• Initial Date FDA Received: 03/26/2018
• Supplement Dates Manufacturer Received: 04/09/2018
• Supplement Dates FDA Received: 04/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1