MAUDE Adverse Event Report: SYNTHES (USA) 1.6MM DRILL TIP GUIDE WIRE 200MM; PIN, FIXATION, SMOOTH

Catalog Number 02.113.001

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

Patient Problem No Code Available (3191)

Event Date 03/09/2017

Event Type  Injury  

Manufacturer Narrative

Additional device product code is hwc.(b)(4).Device is an instrument and is not implanted/explanted.The subject device is not expected to be returned to the synthes manufacturer for evaluation.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 is unknown.Patient code (b)(4) was utilized for additional medical intervention to remove guide wire fragment.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 an initial tibia plateau surgery on (b)(6) 2017 using the 3.5 va-lcp proximal tibia plate set, a 1.6mm guide wire tip broke in the patient.The wire fragment was thrown away.The aiming arm was used to insert and position the 14-hole plate.During screw placement the surgeon was about to remove the k-wire to insert a locking screw but, the plate was too short and the wire broke while surgeon was removing it on reverse.Additional x-rays were taken during the procedure to identify the wire fragment.Several attempts were made to retrieve the guide wire fragment.A screw removal set was used to remove bone to grab the k-wire and it was retrieved.The surgeon inserted a cortex screw instead of using the locking screw.The surgeon used reverse on the drill to remove the threaded guide wire.The surgeon decided to add a locking screw where the guide wire was threaded.There was a surgical delay of 30 minutes.No harm was reported to the patient.The procedure was successfully completed.The patient outcome was reported as stable.Concomitant devices reported: locking/neutral guide for 3.5mm va-lcp prox tibia aiming arm - part# 03.127.010 / unknown lot, quantity x1.1.6mm percutaneous threaded wire guide - part# 03.113.022/ unknown lot, quantity x1.Aiming arm for 3.5mm va-lcp proximal tibia plate- part # 03.127.009/ unknown lot, quantity x1.3.5mm 1va-lcp prox tibia plate/ small bend/ 14 hole 237mm/right- part# 02.127.260 /unknown lot, quantityx1.Cortex screw part# 204.834/unknown lot, quantity x1.This report is 1 of 1 for (b)(4).

• Brand Name: 1.6MM DRILL TIP GUIDE WIRE 200MM
• Type of Device: PIN, FIXATION, SMOOTH
• 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: 6449657
• MDR Text Key: 71392828
• Report Number: 2520274-2017-11132
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080943
• 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: 03/09/2017

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: 02.113.001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/09/2017
• Initial Date FDA Received: 03/31/2017
• 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: 02.127.260, 3.5MM 1VA-LCP PROX TIBIA PLATE, QTY 1; 03.113.022, 1.6MM PERCUT THREADWIRE GUIDE, QTY 1; 03.127.009, AIMING ARM FOR 3.5MM VA-LCP, QTY 1; 03.127.010, LOCK/NTL GUIDE PROXTIBIA AIMARM, QTY 1; 204.834, CORTEX SCREW PART, QTY 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR