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 Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).The actual device has been returned and is currently pending evaluation.Once the investigation has been completed, and if additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported that during an unspecified surgical procedure, it was discovered that the battery reciprocator device was leaking water.It was not reported if there were any delays in the surgical procedure or if a spare device was available for use.There was patient involvement reported.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The exact date of the event was not reported.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.Device evaluation: this device was returned for evaluation.Quality engineering evaluated the device.A visual and functional assessment was performed which determined that there was an unknown liquid coming from the saw head ratchet; failed saw head ratchet check.It was determined that the device would not rotate.Therefore, the reported condition was confirmed.The assignable root cause was determined to be traced to maintenance, which is improper maintenance.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 4436 ; SZ 4436
• MDR Report Key: 9181985
• MDR Text Key: 195903044
• Report Number: 8030965-2019-68981
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 07611819491854
• UDI-Public: 07611819491854
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• 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: 10/09/2019
• Date Manufacturer Received: 11/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1