MAUDE Adverse Event Report: SYNTHES GMBH 1.25MM KIRSCHNER WIRE W/TROCAR POINT 150MM; PIN, FIXATION, SMOOTH

Catalog Number 292.120.01

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/20/2021

Event Type  Injury  

Manufacturer Narrative

Additional patient identifier: (b)(6).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 during the reduction of lisfranc lux fracture procedure on (b)(6) 2021, one of the k needles was fractured, leaving a large part of it inside the bone.The other part remained inside the cannulated drill bit and couldn't be removed.There is no plan for the removal of the remaining part that is left inside the bone.The procedure was completed without any surgical delay.This report is for one (1) 1.25mm kirschner wire w/trocar point 150mm.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D9 h3, h6: part # 292.120.01.Lot # 75p1171.Manufacturing site: balsthal.Release to warehouse date: 23.Oct 2020.A manufacturing record evaluation was performed for the finished device 292.120.01 lot# 75p1171 and no non-conformances were identified.Visual inspection: 2.7mm cannulated drill bit qc 160mm (p/n: 310.670, lot #: f-20550) was returned and received at us customer quality (cq) along with a broken device that was stuck inside the cannulated drill bit.The broken device is potentially the alleged "k-wire ø1.25 l150 sst" (p/n: 292.120.01, lot #: 75p1171) per the event description.No other issues were identified.The reported condition of embedded device could not be confirmed as no x-rays were provided.Device failure/defect identified? yes.Functional test: a functional test was performed to disassemble the device stuck inside.The device stuck inside could not be removed.Hence, confirming the complaint condition.Can the complaint be replicated with the returned devices? yes.Document/specification review: the current and manufactured revision of drawings were reviewed: 2.7mm dia.Cannulated drill with quick coupling, 160mm kirschner wires with trocar tip no design issues or discrepancies were identified.Dimensional inspection: complaint relevant dimensional analysis cannot be performed device could not be accessed without the destruction of the mating device.Complaint confirmed? yes.Investigation conclusion the complaint condition could be confirmed for the returned device.There is no indication that a design or manufacturing issue has caused the issue.No product design or manufacturing issues were identified, and no new malfunctions were identified either.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 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.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 KIRSCHNER WIRE W/TROCAR POINT 150MM
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12488483
• MDR Text Key: 271915907
• Report Number: 8030965-2021-07840
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 07611819319660
• UDI-Public: (01)07611819319660
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.120.01
• Device Lot Number: 75P1171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Date Manufacturer Received: 10/11/2021
• Patient Sequence Number: 1
• Treatment: 2.7MM CANNULATED DRILL BIT QC 160MM; 2.7MM CANNULATED DRILL BIT QC 160MM
• Patient Outcome(s): Required Intervention