MAUDE Adverse Event Report: SYNTHES SELZACH 1.25MM THREADED GUIDE WIRE 150MM; WIRE, SURGICAL

Catalog Number 292.620S

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/05/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: additional device product code is hty.(b)(4).The subject device is expected to be returned to the synthes manufacturer for evaluation but has not yet been received.(b)(6).Device history record reviews were performed for the subject device lot.Non-sterile part # 292.620/ lot # 9829627, manufacturing location: (b)(4), manufacturing date: 8th february 2016.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Sterile part # 292.620, lot # 9840874, manufacturing location: (b)(4), supplier: (b)(4), manufacturing date: 24th february 2016, expiry date: 1st february 2026.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Synthes europe reported an event in (b)(6) as follows: it was reported that a 1.25mm threaded guide wire 150mm broke during a distal fracture procedure of the tibia and fibula on (b)(6) 2016.A distal fibula plate and a locking compression plate (lcp) clover plate were used.In order to fix the rear bone pieces with a 4.0mm cannulated screw system (css), the surgeon inserted a guide wire from the distal frontal tibia.Due to the improper positioning, surgeon turned the drill counterclockwise to remove the guide wire.This resulted in the guide wire cutting off from the screw area.Surgeon made a small skin incision and decided not to take the broken part out of the patient.It is unknown if fragments were generated and if a new guide wire was used to proceed.Procedure was successfully completed.No surgical delay reported.There is no plan to reoperate.Concomitant devices reported: distal fibula plate (part# unknown, lot # unknown, qty 1), lcp clover plate (part # unknown, lot # unknown, qty 1), 4.0mm ccs (part# unknown, lot # unknown, qty 1).This is report number 1 of 1 for complaint (b)(4).

• Brand Name: 1.25MM THREADED GUIDE WIRE 150MM
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6051791
• MDR Text Key: 58205934
• Report Number: 3000270450-2016-10249
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PREAMEND
• 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
• Report Date: 10/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.620S
• Device Lot Number: 9840874
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 4.0MM CCS; DISTAL FIBULA PLATE; LCP CLOVER PLATE
• Patient Outcome(s): Required Intervention