MAUDE Adverse Event Report: SYNTHES USA 1.6MM KIRSCHNER WIRE W/TROCAR POINT 150MM; WIRE, SURGICAL

Catalog Number 292.16

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/13/2016

Event Type  Injury  

Manufacturer Narrative

Additional product code: hty.(b)(4).Device broke during insertion; device not considered implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation as it was reportedly discarded.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.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.

Event Description

It was reported that during a distal humerus fracture repair, two instruments broke intra-operatively.A guide wire tip broke off, and the tip fragment remains implanted in the patient.In addition, the drill bit tip broke, and all fragments were retrieved (confirmed by intraoperative x-ray).There were other devices available to use; the surgery was completed successfully.There was no reported surgical delay or harm to the patient.(b)(4).

• Brand Name: 1.6MM KIRSCHNER WIRE W/TROCAR POINT 150MM
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): SYNTHES USA; 1302 wrigths lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5628535
• MDR Text Key: 44301439
• Report Number: 2520274-2016-12463
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PPREAMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR