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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA 2.0MM KIRSCHNER WIRE W/TROCAR POINT 150MM PIN, FIXATION, SMOOTH

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SYNTHES USA 2.0MM KIRSCHNER WIRE W/TROCAR POINT 150MM PIN, FIXATION, SMOOTH Back to Search Results
Catalog Number 292.20
Device Problem Material Fragmentation
Event Date 03/02/2015
Event Type  Malfunction  
Event Description

It was reported that a k-wire broke during a procedure to repair an olecranon fracture. As the surgeon was putting on the olecranon plate and started to pin it down with k-wire, it broke. A partial piece of the wire was left in the patient. There were no delays reported and the procedure was successfully completed. This is report 1 of 1 for complaint (b)(4).

 
Manufacturer Narrative

Device was used for treatment, not diagnosis. Additional narrative: investigation could not be completed and no conclusion could be drawn as no device was returned and no lot was provided. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Manufacturer Narrative

(b)(6). Device is an instrument and is not implanted/explanted. Device initially reported as adverse event and product problem/malfunction. Device should be product problem/malfunction only. Device was used for treatment, not diagnosis. 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. (b)(4). A product development investigation was performed for the subject device. The tip of the returned device is broken off and was not returned. Since the tip was not returned, the exact part number could not be confirmed with respect to the reported part number. There are multiple roll marks on the shaft of the device. It is unknown what caused the complaint condition, but it is likely that off axis forces contributed to the failure of the device. A visual inspection, complaint history review, drawing review, and risk assessment review were performed as part of this investigation. No product design issues or discrepancies were observed. Although the exact cause cannot be determined, this complaint condition is likely a result of method of use and not the device's design. Because of this, the complaint is determined not to be a result of a detected design deficiency. The returned part is determined to be suitable for their intended use when used and maintained as recommended. This complaint is confirmed, but the design of the device did not contribute to this complaint. Event is serious injury for device fragment in patient and product problem. Required intervention. (b)(4). 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: the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
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Brand Name2.0MM KIRSCHNER WIRE W/TROCAR POINT 150MM
Type of DevicePIN, FIXATION, SMOOTH
Manufacturer (Section D)
SYNTHES USA
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
linda plews
1302 wrights lane east
west chester , PA 19380
6107195000
MDR Report Key4628272
Report Number2520274-2015-12058
Device Sequence Number1
Product CodeHTY
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 03/09/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/24/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number292.20
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/08/2015
Is The Reporter A Health Professional? No
Date Manufacturer Received06/10/2015
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 03/24/2015 Patient Sequence Number: 1
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