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

Catalog Number 292.16

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).Device was not implanted nor explanted, fragment still remains in patient.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.(b)(4) the report states after noticing the malfunction on x-ray, a piece of the instrument was retrieved.At the time of this review, and with the information available, it appears a fragment remained in the patient.If additional information becomes available, this determination should be sent back for review.Subject device has not been received.Without a lot number, the device history record review and 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.

Event Description

Complaint handling unit received a maude report forwarded from department of human services; this report is against user facility#(b)(4).Only additional and/or corrected information will be contained in this report.It was reported that during a procedure on (b)(6) 2016 the k-wire driver that was used, partially broke off in the patient's right arm.This complaint involves 1 device.This report is 1 of 1 for (b)(4).

• Brand Name: 1.6MM KIRSCHNER WIRE W/TROCAR POINT 150MM
• Type of Device: WIRE,SURGICAL
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5707347
• MDR Text Key: 46854651
• Report Number: 2520274-2016-13070
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• PMA/PMN Number: PPREAMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 292.16
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2016
• 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: 54 YR