MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH K-WIRE Ø1.25 THREAD-TIP L200/15 SST; WIRE, SURGICAL

Catalog Number 292.703

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/21/2019

Event Type  Injury  

Manufacturer Narrative

Device is not distributed in the united states, but is similar to device marketed in the usa.Without a lot number the device history records review could not be completed.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 an unknown procedure on (b)(6) 2019 for dens fracture, three (3) guide wires broke off while making the trajectory.One piece was left in the dens, past the fracture hearth.Thus, the patient can no longer have a nuclear magnetic resonance (nmr) scan as the piece will interfere with the result.Fragments were generated and easily retrieved.There was a surgical delay of 45 minutes.The procedure and patient outcome were unknown.This report captures synthes trauma devices while related complaint (b)(4) captures synthes spine devices.This report is for one (1) k-wire ø1.25 thread-tip l200/15 sst.This is report 2 of 2 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.Visual inspection: two k-wires with threaded tip were returned.The tip of both k- wires is broken as complained.Only one broken tip was returned for investigation, unfortunately it was not possible to allocate the tip to the respective lot number of the k-wire.Dimensional inspection: although the exact production period is not known the relevant dimension (outer diameter) was checked based on the actual valid drawing.The outer diameter measured near the breakage is 1.23mm which comply with the specifications drawing/specification review: could not be performed due to missing information ¿ lot number is unknown material /hardness review: could not be performed due to missing information ¿ lot number is unknown summary the complaint condition is confirmed as the tip of the k- wire is broken.Since the exact lot number is not known the manufacturing records could not be verified.However, dimensional inspection confirmed conformity to the specifications.A definitive root cause could not be determined; it is likely that any unintended excessive forces during usage could have contributed to complaint condition.Risk documentation review confirmed that this complaint condition is adequately covered by the risk assessment.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: K-WIRE Ø1.25 THREAD-TIP L200/15 SST
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8370765
• MDR Text Key: 137170843
• Report Number: 8030965-2019-61446
• Device Sequence Number: 1
• Product Code: LRN
• UDI-Device Identifier: 07611819110267
• UDI-Public: (01)07611819110267
• Combination Product (y/n): N
• 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: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Initial Date Manufacturer Received: 01/29/2019
• Initial Date FDA Received: 02/26/2019
• Supplement Dates Manufacturer Received: 03/11/2019
• Supplement Dates FDA Received: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention