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

Catalog Number 292.620S

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/13/2021

Event Type  malfunction  

Manufacturer Narrative

Additional device product codes: hty.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent the open reduction internal fixation for trimalleolar fracture of ankle with the guide wire.During the surgery, a cannulated cancellous screw 4.0 was used for fractures of the distal medial malleolus of the tibia.When the surgeon inserted the guide wire into the bone, and drilled after measuring, it was confirmed by x-ray that the guide wire came out together with the drill bit.The surgeon tried to remove the guide wire from the drill bit using a stylet, but he could not remove the guide wire at all.Due to the material of the stylet being soft, the surgeon could not operate the stylet well.As a result, the guide wire could not be taken out of the drill bit.Therefore, the surgeon considered fixing the screw using a hospital-owned k-wire 1.2 mm as a substitute for the guide wire.When checked again with an x-ray, it was confirmed that the tip of the guide wire had been broken and placed in the bone.The fragment was removed using a mosquito forceps and an alternative hollow drill.The surgery was completed successfully within 30minutes delay.This report involves one (1) 1.25mm threaded guide wire 150mm.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: investigation summary: the product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that guidewire ø1.25 w/thread-tip w/trocar l1 the device was broken, and broken piece was not returned no other issues were identified.The dimensional inspection was not performed due to post manufacturing damage.The observed condition guidewire ø1.25 w/thread-tip w/trocar l1 in the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed broken condition of the guidewire ø1.25 w/thread-tip w/trocar l1.While no definitive root cause could be determined, it is probable that the guidewire ø1.25 w/thread-tip w/trocar l1 was broken due to the unintended forces.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: part: 292.620s.Lot: 7l50581.Manufacturing site: selzach.Supplier: (b)(4).Release to warehouse date: 18 november 2020.Expiration date: 01 november 2030.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Non-sterile: part: 292.620.Lot: 74p0672.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.

• Brand Name: 1.25MM THREADED GUIDE WIRE 150MM
• Type of Device: WIRE,SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12453594
• MDR Text Key: 270823710
• Report Number: 8030965-2021-07636
• Device Sequence Number: 1
• Product Code: LRN
• UDI-Device Identifier: 07611819733121
• UDI-Public: (01)07611819733121
• Combination Product (y/n): N
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.620S
• Device Lot Number: 7L50581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Initial Date Manufacturer Received: 08/13/2021
• Initial Date FDA Received: 09/10/2021
• Supplement Dates Manufacturer Received: 09/30/2021
• Supplement Dates FDA Received: 10/08/2021
• Patient Sequence Number: 1
• Treatment: 2.7MM CANNULATED DRILL BIT QC 160MM; CLEAN-STYLET Ø1.25; UNK - SCREWS: 4.0 MM CANNULATED; 2.7MM CANNULATED DRILL BIT QC 160MM; CLEAN-STYLET Ø1.25; UNK - SCREWS: 4.0 MM CANNULATED