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 Intermittent Energy Output (4025)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Device evaluation: the actual device was returned for evaluation.During repair, it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported by (b)(6) that during service and evaluation, it was determined that the motor of the battery reciprocator device was damaged.It was further determined that the device would not run.It was observed that the motor was interrupted.It was further determined that the device failed pretest for check oscillation frequency, minimum 12600 - 16000 oscillation/minute, check trigger and ecu (electric control unit) function and functional test.It was noted in the service order that the device did not work anymore.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.All available information has been disclosed.If additional information should available, a supplemental medwatch 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 4436 ; SZ 4436
• Manufacturer (Section G): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 8838060
• MDR Text Key: 152561458
• Report Number: 8030965-2019-66591
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 07611819491854
• UDI-Public: 07611819491854
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/07/2019

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: 530.715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Initial Date Manufacturer Received: 07/18/2019
• Initial Date FDA Received: 07/29/2019
• Date Device Manufactured: 12/10/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1