MAUDE Adverse Event Report: SYNTHES OBERDORF BATTERY RECIPROCATOR; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 530.615

Device Problems Bent (1059); Break (1069); Loss of Power (1475); Device Contamination with Chemical or Other Material (2944); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 09/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device had no power, did not function and had a sticky trigger.It was further determined that the electric motor emitted an unusual noise, there was an unknown substance on the internal components, the wire insulation on electronic control unit was damaged and the stop ring on trigger was bent.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to component wear caused by normal use and servicing over time.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 that during pre-surgery setup, it was observed that the battery reciprocator device had no power.During in-house engineering evaluation, it was observed that the device had no power, had a sticky trigger and did not function.It was further determined that the electric motor emitted an unusual noise, there was an unknown substance on the internal components, the wire insulation on electronic control unit was damaged and the stop ring on trigger was bent.There were no delays to the planned surgical procedure.A spare identical device was available for use.There was no 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.

• Brand Name: BATTERY RECIPROCATOR
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer (Section G): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6072416
• MDR Text Key: 59296146
• Report Number: 8030965-2016-15426
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 09/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2016
• 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: 2614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2016
• Date Manufacturer Received: 10/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1