MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 1.6MM NON-THREADED GUIDE WIRE TROCAR POINT 220MM; PIN,FIXATION,SMOOTH

Model Number 02.226.001

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Patient identifier and date of birth not available for reporting.Additional product code: hwc.(b)(4).Lot unknown.Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is not expected to be returned for manufacturer review/investigation.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

It was reported during an initial mid-foot procedure on (b)(6) 2017 a kirschner wire broke intraoperatively.The wire broke while the surgeon was drilling for a cannulated screw placement in the foot.The wire was embedded in the patient bone and no attempt was made to retrieve the fragments.No surgical delay occurred.The surgeon continued with the procedure.The procedure was completed successfully.Patient was stable postoperatively.Concomitant device reported: drill bit (part number unknown, lot number unknown, quantity 1).This is report 1 of 1 for (b)(4).

• Brand Name: 1.6MM NON-THREADED GUIDE WIRE TROCAR POINT 220MM
• Type of Device: PIN,FIXATION,SMOOTH
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK BALSTHAL (CH); dornacherstrasse 20; balsthal 4710 ; SZ 4710
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7145973
• MDR Text Key: 96235349
• Report Number: 2939274-2017-50419
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 10886982057655
• UDI-Public: (01)10886982057655(10)LOTUNKNOWN
• 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: Health Professional
• Type of Report: Initial
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.226.001
• Device Catalogue Number: 02.226.001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2017
• Initial Date FDA Received: 12/26/2017
• 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 Age: 49 YR
• Patient Weight: 147