MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.0MM KIRSCHNER WIRE W/15MM THREAD-TROCAR POINT 150MM; PIN, FIXATION, THREADED

Catalog Number 292.790

Device Problems Break (1069); Entrapment of Device (1212); Device-Device Incompatibility (2919)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 02/04/2020

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Occupation: synthes employee.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.(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

Device report from synthes reports an event in (b)(6) as follows: it was reported on (b)(6) 2020 that the guide needles are passed to determine the anteversion of the femoral neck and the tip of the guides remain inside the femoral neck because of their location cannot be removed.The surgery was not delayed, it was completed successfully.The remaining parts of the guides are sent.This is 1 of 2 for report (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.H3, h6: part: 292.790.01, lot: 4l12693, manufacturing site: balsthal, release to warehouse date: 01.Apr.2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the k-wire (part # 292.790, lot # 4l12693, mfg # 01-apr-2019) was received at us customer quality (cq) with the distal tip of the k-wire broken off and not returned.This is consistent with the reported complaint condition, thus confirming the complaint.X-rays were not returned to us cq therefore the embedded condition of the tip of the device could not be confirmed.Dimensional inspection: dimensional analysis was completed, the outer diameter of the threaded distal tip closest to the shaft, measured within specification.Document/specification review: the following drawing(s) was reviewed; k-wire ø2 thread ¿ tip l = xxx/15.Conclusion: there is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.H6: device code 2919 updated to 1069.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: 2.0MM KIRSCHNER WIRE W/15MM THREAD-TROCAR POINT 150MM
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9751016
• MDR Text Key: 189313542
• Report Number: 8030965-2020-01392
• Device Sequence Number: 1
• Product Code: JDW
• UDI-Device Identifier: 07611819320017
• UDI-Public: (01)07611819320017
• 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: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.790
• Device Lot Number: 4L12693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Date Manufacturer Received: 03/12/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR
• Patient Weight: 50