MAUDE Adverse Event Report: SYNTHES OBERDORF SMALL BATTERY DRIVE; INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH

Catalog Number 532.010

Device Problem Failure to Run on Battery (1466)

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

Event Date 02/06/2014

Event Type  malfunction  

Event Description

Facility reporter advised the 532.010 (small battery drive) stopped working during a surgery.No further information was provided.Update: the reported event happened during triple plateau leveling osteotomy, there was a 2 minutes delay due to reported event, and a spare device was used to complete the procedure.The procedure was completed successfully without any medical intervention.This is report (1) of (1) for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Subject device has been received and is currently in the evaluation process.Investigation is on going; no conclusion could be drawn.Device is an instrument and is not implanted/explanted.Device was used in veterinary case, patient information will not be provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Service history of the past six months from the awareness date was reviewed.No service history review can be performed.The item has not been in for service for the past six months.There is no information relevant to the current complained issue.The customer's complaint that the ((b)(4)) small battery drive does not function was confirmed.The unit was tested and did not run when power was applied.Evidence indicates this is due to usage wear over time.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: surgical procedure - cruciate repair.Not previously reported.Quantity: one power device.Not previously reported.The device is an instrument, not implanted/explanted.Not previously reported.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

On 9/10/2014 update - additional information was provide by faxed facility signed questionnaire received on (b)(4) 2014.The small animal surgery supervisor reported: the event took place on (b)(6) 2014 while the surgeon was performing cruciate repair on an unknown species.This reported event is for 1 device.

• Brand Name: SMALL BATTERY DRIVE
• Type of Device: INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH
• 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: 3676916
• MDR Text Key: 4255652
• Report Number: 2520274-2014-10200
• Device Sequence Number: 1
• Product Code: HWE
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.010
• Device Lot Number: 004352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/10/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/20/2011
• 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