MAUDE Adverse Event Report: SYNTHES GMBH 2.0MM KIRSCHNER WIRE W/TROCAR POINT 150MM; WIRE, SURGICAL

Catalog Number 292.200S

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; 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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the patient underwent for an unknown procedure.During the procedure, one k-wire was broke.It was unknown if the surgery completed successfully without delay.It was unknown if there was any fragment generated.The patient outcome unknown.This complaint involves one (1) device.This report is for (1) k-wire ø2 l150 sst.This report is 1 of 1 for (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.D2b: additional device product code: hty.G4 h6: product was not returned.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.A device history record (dhr) review was conducted: sterile - part part: 292.200s, lot: 7l44025.Manufacturing site: selzach, supplier: (b)(4).Release to warehouse date: 27.Oct.2020 expiry date: 01.Oct.2030.Since there is no allegation against packing or sterility dhr review is done for non-sterile part: non - sterile - part part: 292.200.10.Lot: 71p4585.Manufacturing site: balsthal.Release to warehouse date: 08.Oct.Part: 292.200.10, lot: 71p4585.Manufacturing site: balsthal.Release to warehouse date: 08.Oct.2020.A manufacturing record evaluation was performed for the finished device lot number 71p4585, and no non-conformances were identified.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/TROCAR POINT 150MM
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11135473
• MDR Text Key: 226101528
• Report Number: 8030965-2021-00153
• Device Sequence Number: 1
• Product Code: LRN
• UDI-Device Identifier: 07611819265059
• UDI-Public: (01)07611819265059
• 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: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.200S
• Device Lot Number: 7L44025
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2021
• Patient Sequence Number: 1