MAUDE Adverse Event Report: SYNTHES SELZACH K-WIRE Ø1.25 THREAD-TIP L150/5 SST; WIRE, SURGICAL

Catalog Number 292.663S

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/10/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information not available for reporting.(b)(4).Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Hospital telephone: (b)(6).Device is not distributed in the united states, but is similar to device marketed in the usa.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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 the (b)(6) as follows: it was reported that during an unknown surgery on march 10, 2017 the kirschner wire (k-wire) broke while being inserted into the distal tibia.The surgeon was unable to remove the k-wire.No surgical delay is reported.No information available about patient condition and outcome.This report is for one (1) stainless steel kirschner wire with treaded tip this is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A device history record review was performed for the subject device lot number l030664.Manufacturing location: (b)(4).Date of manufacture: 22.June 2016.Expiration date: 01.June 2026.The review showed that there were no issues during the manufacture or sterilization of the product that would contribute to this complaint condition.No non-conformance were generated during the production or sterilization of the subject device.Device was first manufactured unsterile under the lot l015245 in balsthal and repacked/sterilized afterwards.As this complaint is neither packaging nor sterilization related only the manufacturing documents of the unsterile device 292.663.10 (package of 10 pieces) with lot l015245 were reviewed: no ncrs were generated during production of the unsterile part 292.663.10 with lot l015245.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The procedure was successfully completed.There was a delay but it is unknown how long.They would have been using x-ray guidance for the case.

• Brand Name: K-WIRE Ø1.25 THREAD-TIP L150/5 SST
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6904262
• MDR Text Key: 89501205
• Report Number: 3000270450-2017-10343
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.663S
• Device Lot Number: L030664
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1