MAUDE Adverse Event Report: SYNTHES SELZACH GUIDEWIRE Ø1.25 W/THREAD-TIP W/TROCAR L1; WIRE,SURGICAL

Catalog Number 292.620S

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

Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient information not available for reporting.Unknown when device broke.Additional product code: hty.(b)(6).This report is for a guidewire ø1.25 w/thread-tip w/trocar l1.The 510k# unknown: device is not distributed in the united states, but is similar to device marketed in the usa device is not expected to be returned for manufacturer review/investigation.(b)(6).It was reported that a guide wire broke during surgery, as a direct result of using a blunt drill bit.The guide wire broke inside the patient, and the fragments remain in the patient.Device history records review was conducted.The report indicates that the: lot 9733073 / unsterile 9682651, manufacturing site: (b)(4) supplier: (b)(4), manufacturing date: 19.Nov.2015 expiry date: 01.Nov.2025, part was first manufactured unsterile in (b)(4) under the lot 9682651, as the complaint is not related to sterilisation or packaging only the documents of the unsterile lot were reviewed: no ncrs were generated during production.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

Device report from synthes on an event in (b)(6) as follows: it was reported that a guide wire broke during surgery.The surgeon was previously unhappy about the drill bit and reported it as blunt, he was given another drill bit from another set, these are reused drill bits.He later reported that the guide wire was broken inside the patient and this was a direct result of using a blunt drill bit.Additional information received 15.June 16: three articles were affected in total 2x guide wire and 1x drill bit.The broken off pieces were left in the patient.This report is 2 of 3 for (b)(4).

Manufacturer Narrative

Updated cia: two guide wires, 1.25mm, with threaded-tip with trocar, length 150mm (part number 292.620, lot 9894439 & 9733073) was reported as broken, but was not returned for further evaluation.Without product an investigation or a root cause cannot be performed/defined.The dhr review shows that the devices met the specifications at the time of manufacturing and distributing.Device 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

Updated 02.August 2016:.

• Brand Name: GUIDEWIRE Ø1.25 W/THREAD-TIP W/TROCAR L1
• 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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5758328
• MDR Text Key: 48445484
• Report Number: 3000270450-2016-10161
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PPREAMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2016
• 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: 9733073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention