MAUDE Adverse Event Report: SYNTHES (USA) K-WIRE Ø1.8 L280 SST 10U; PASSER,WIRE,ORTHOPAEDIC

Catalog Number 292.190.10

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/27/2017

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient weight is not available for reporting.(b)(4).Device is an instrument and is not implanted/explanted.The subject device is expected to be returned to the synthes manufacturer for evaluation but has not yet been received.Reporting facility phone numbers are (b)(6).510(k): device is not distributed in the united states, but is similar to device marketed in the usa.The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number the device history records review could not be completed.The date of manufacture and expiration date are unknown.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report synthes europe reported an event in (b)(6) as follows: it was reported that during an unspecified surgery on (b)(6) 2017 the head of the k-wire broke off and the fragment was retained in the patient.It was further reported that the k-wire was inserted through the guide without any force or pressure.The reported issue was discovered when x-rays were taken.There was no surgical delay.Reported concomitant devices: guide (part / lot: unknown, quantity: 1).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

The review of the received x-ray, it can be confirmed that the device was embedded.(b)(4).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

Reported concomitant devices: positioner for aiming block (part: 03.108.006, lot: unknown, quantity: 1).

Manufacturer Narrative

Device was used for treatment, not diagnosis.The reported information from the device report has indicated that the wire was un-headed and remained within the patient¿s bone.Without having the subject device, synthes cannot provide a conclusive statement regarding the possible failure reason.No further information, as well as the lot number, had been made available therefore an investigation could not be performed.Since the lot number is not known, synthes could not verify the production documents.The review of the x-rays reviewed by synthes confirmed the complaint condition regarding the embedded device (as previously reported).A root cause cannot be determined.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: K-WIRE Ø1.8 L280 SST 10U
• Type of Device: PASSER,WIRE,ORTHOPAEDIC
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6419827
• MDR Text Key: 70411909
• Report Number: 2520274-2017-10948
• Device Sequence Number: 1
• Product Code: HXI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.190.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2017
• Initial Date FDA Received: 03/21/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/02/2017; 05/04/2017
• 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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN GUIDE, QUANTITY 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR