MAUDE Adverse Event Report: SYNTHES OBERDORF BATTERY OSCILLATOR II FOR BPL II; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 530.710_LL

Device Problems Device Operates Differently Than Expected (2913); Device Damaged by Another Device (2915)

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

Event Date 11/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(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

This is event 1 of 2 of the same event.It was reported that during an unspecified surgical procedure, it was discovered that the battery oscillator device damaged multiple batteries devices because it would not turn.It was unknown how many batteries were damaged.According to the reporter some surgeries were rescheduled because no battery devices were available.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

The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device did not work at all, the control unit potted was damaged and shorted and the device had an unknown liquid inside the control.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to improper cleaning.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: during subsequent follow-up, additional information was received.It was reported that a large number of batteries were used and failed due to the failure experienced from the large bone orthopedic battery oscillator device.It was further reported that seven patients were inconvenienced by this device failure in that their procedures were either delayed or rescheduled to a later date.It was reported that there were no serious injuries or death.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: BATTERY OSCILLATOR II FOR BPL II
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6147214
• MDR Text Key: 61869481
• Report Number: 8030965-2016-15824
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.710_LL
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/01/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2015
• 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
• Treatment: BATTERY DEVICES