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

Catalog Number 292.160

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nerve Damage (1979); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device has not been reported as explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).(b)(4).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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a male patient, born in (b)(6) had postoperative nerve injury which lead to a reoperation.The patient initially underwent a procedure on (b)(6) 2014 to implant a philos plate with cement augmentation due to a three-part fracture of the proximal humerus.The patient presented with symptoms of pain and partial loss of function in the right hand.On (b)(6) 2015, the patient underwent exploration of the right plexus brachialis.The implants are still in the patient.The patient recovered without persistent damage.This is report 13 of 13 for (b)(4).

Manufacturer Narrative

Additional narrative: 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 the pain the patient had presented with was in his index finger and thumb.

• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5492110
• MDR Text Key: 40057786
• Report Number: 2520274-2016-11583
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 292.160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2016
• 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 Weight: 100