MAUDE Adverse Event Report: SYNTHES USA 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); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 06/05/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).Not implanted or explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.(b)(6).Device history records was conducted.The report indicates that the: lot is either 9733073 or 9894439.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 balsthal 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.Lot 9894439 / unsterile 9881137, manufacturing site: (b)(4), supplier: (b)(4), manufacturing date: 05.April.2016, expiry date: 01.Mar.2026.Part was first manufactured unsterile in balsthal under the lot 9881137, 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.This complaint involves 1 part.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

(b)(4).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

Update 24 june 2016 - additional information received 15 june 2016: 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 1 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 USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5740173
• MDR Text Key: 47893951
• Report Number: 2520274-2016-13242
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PPREADM
• 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,Followup
• Report Date: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.620S
• 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
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention