MAUDE Adverse Event Report: SYNTHES OBERDORF BATTERY RECIPROCATOR; BATTERY, REPLACEMENT, RECHARGEABLE

Catalog Number 530.615

Device Problem Loss of Power (1475)

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

Event Date 03/20/2014

Event Type  malfunction  

Event Description

It was reported that prior to surgery, it was observed that the battery reciprocator device had no power.There were no delays to the planned surgical procedure.A spare identical device was available for use.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

(b)(6).The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device would not rotate.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to internal motor or electronic control unit damage by immersion during cleaning which is misuse, abuse and or/ user error.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: BATTERY RECIPROCATOR
• Type of Device: BATTERY, REPLACEMENT, RECHARGEABLE
• Manufacturer (Section D): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH44 36; SZ CH4436
• Manufacturer (Section G): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH44 36; SZ CH4436
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4774806
• MDR Text Key: 5795457
• Report Number: 8030965-2015-10818
• Device Sequence Number: 1
• Product Code: MOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2014

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: 530.615
• Device Lot Number: 2899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2014
• Initial Date Manufacturer Received: 03/24/2014
• Initial Date FDA Received: 05/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1