MAUDE Adverse Event Report: SYNTHES OBERDORF QC F/K-WIRES Ø0.6-3.2 F/532.001 532.010; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 532.022

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Noise, Audible (3273)

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

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

It was reported that during an unspecified surgical procedure, it was discovered that the quick coupling for k-wires device stopped working suddenly even after the battery was changed.It was further reported that the user tested the device the next day and it worked fine except it emitted an unusual sound.It was unknown if there was a delay to the planned surgical procedure or if a spare device was available for use.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.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 was returned for evaluation.Reliability engineering evaluated the device and observed that the device coupling tool side was worn out.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to normal wear from 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.

• Brand Name: QC F/K-WIRES Ø0.6-3.2 F/532.001 532.010
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• 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: 6036191
• MDR Text Key: 57857750
• Report Number: 8030965-2016-15206
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2005
• 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