MAUDE Adverse Event Report: SYNTHES (USA) 2.0MM K-WIRE W/DRILL TIP-150MM; PLATE, FIXATION, BONE

Catalog Number 02.111.903.01

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/09/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient weight is not available for reporting.Additional device product code is hwc.(b)(4) lot number unknown.Device is an instrument and is not implanted/explanted.The subject device is not expected to be returned to the synthes manufacturer for evaluation.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 manufacture date: unknown.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 during an ulna osteotomy procedure on (b)(6) 2016 the 2.0mm k-wire with drill tip was broken intraoperatively.The breakage and fragmentation were noted at the end of the procedure during routine x-ray when a fragment was viewed in the patient's bone.The surgeon was not able to retrieve the fragment.There was no surgical delay associated with the k-wire breakage.The procedure was completed successfully.This report is 1 of 1 for (b)(4).

• Brand Name: 2.0MM K-WIRE W/DRILL TIP-150MM
• Type of Device: PLATE, FIXATION, BONE
• 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: 5900940
• MDR Text Key: 52903583
• Report Number: 2520274-2016-14341
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113364
• 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: 08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.111.903.01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/09/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR