MAUDE Adverse Event Report: SYNTHES SELZACH 1.6MM NON-THREADED GUIDE WIRE TROCAR POINT 220MM-STERILE; PIN,FIXATION,SMOOTH

Catalog Number 02.226.001S

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/08/2017

Event Type  Injury  

Manufacturer Narrative

Additional narrative: patient identifier and weight are not available for reporting.Additional code: hwc.Two (2) possible lot numbers reported.Lot number 9902157, manufacture date april 8, 2016, expiration date march 1, 2026.(b)(4).Lot number l039203, manufacture date june 27, 2016, expiration date june 1, 2026.(b)(4).Device was not implanted or explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Concomitant device, part 03.226.039, partial lot number l225x4.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.Article 02.226.001s with lot 9902157 please note, this dhr review is for sterilization procedure only manufacturing location: (b)(4), supplier: (b)(4), manufacturing date: 08.Apr.2016 expiry date: 01.Mar.2026.No ncrs 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.Non-sterile 02.226.001 / 9879022.Manufacturing location: (b)(4), manufacturing date:11.Mar.2016.No ncrs 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.Article 02.226.001s with lot l039203.Please note, this dhr review is for sterilization procedure only, manufacturing location: (b)(4), supplier: (b)(4), manufacturing date: 27.Jun.2016 expiry date: 01.Jun.2026.No ncrs 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.Non-sterile 02.226.001 / 9965823.Manufacturing location: (b)(4), manufacturing date: 24.May.2016.No ncrs 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.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 europe reports an event in (b)(6) as follows: it is reported during a calcaneal fracture procedure on (b)(6) 2017; while surgeon was drilling a guide wire broke.The broken fragment remains embedded in the patient.Surgeon used another guide wire to insert a screw and used a jacobs chuck when inserting the guide wire.No surgical delay or need for other medical intervention was required.Patient status reported as good.Concomitant devices reported: jacobs chuck (part number unknown, lot number unknown, quantity 1), drill bit (part 03.226.039, lot number unknown, partial lot l225x4, quantity 1), screw (part number unknown, lot number unknown, quantity 1).This report is for one (1) guide wire.This is report 1 of 1 for (b)(4).

• Brand Name: 1.6MM NON-THREADED GUIDE WIRE TROCAR POINT 220MM-STERILE
• Type of Device: PIN,FIXATION,SMOOTH
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6473022
• MDR Text Key: 72173845
• Report Number: 3000270450-2017-10122
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K080943
• 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: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.226.001S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2017
• 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
• Treatment: DRILL BIT (PART 03.226.039, LOT UNKNOWN, QTY 1); JACOBS CHUCK (PART AND LOT UNKNOWN, QTY 1); SCREW (PART AND LOT UNKNOWN, QTY 1)
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR