MAUDE Adverse Event Report: SYNTHES USA 1.25MM PLATE REDUCTION WIRE THRDD TIP W/LG STOP/150MM; PIN, FIXATION, SMOOTH

Catalog Number 02.111.501

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/18/2014

Event Type  malfunction  

Event Description

It was reported that during an open reduction internal fixation(orif) of a distal radius fracture, the distal aspect of the tip of a k-wire broke off in the distal aspect of a plate near the volar surface.When the tip broke off it was impacted and could not be removed.There was no surgical delay nor harm to the patient.The procedure was completed successfully.This is report 1 of 1 for complaint com-(b)(4).

Manufacturer Narrative

Device used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.Without a lot number, the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 1.25MM PLATE REDUCTION WIRE THRDD TIP W/LG STOP/150MM
• Type of Device: PIN, 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 Key: 4415034
• MDR Text Key: 5166060
• Report Number: 2520274-2015-10328
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK102694
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.111.501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2014
• Initial Date FDA Received: 01/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR