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

Catalog Number 292.62

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

Additional device product code: (b)(4).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) 2020, there were problems with 4.0 css guide wires.Several guide wires twisted when they were inserted into the patient.Some of the wires even broke during drilling, and some have a step in the wire caused by drill bit.No further information provided.This report is for one (1) 1.25mm threaded guide wire 150mm.This is report 4 of 4 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.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

Additional event information concomitant device reported: unknown drill bit (part #: unknown, lot #: unknown, quantity: 1).

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, h4, h6: part: 292.620, lot: 42p4943, manufacturing site: balsthal, release to warehouse date: 27.Feb 2020.A manufacturing record evaluation was performed for the finished device lot number 42p4943, and no non-conformances were identified.Visual inspection: two guide wire's with the same lot number were received at customer quality zuchwil.Both guide wire's are intact (not broken) and deformed.There are several heavy marks and usage signs on the entire surface visible.All features related to the reported complaint condition were reviewed and no other issues were identified.Dimensional inspection: feature: diameter for guide wire 1, result: pass.Feature: diameter for guide wire 2, result: pass.Drawing/specification review: the manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Furthermore, as indicated in the manufacturing documents, the correct material was used according iso 5832-1 summary: our investigation shows that the both guide wire's are not broken as described in the complaint description.However this complaint will be rated as confirmed for the damages incurred.The for the complaint relevant dimensions were checked as far as possible and found to be within specifications.This and the findings above let us exclude a manufacturing related issue.Due to the condition of both devices, "deformation", it is likely that an unintended handling issue has taken place which has finally lead to reported malfunction.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.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 as no product related issue could be detected.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): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10730553
• MDR Text Key: 212990585
• Report Number: 8030965-2020-08146
• Device Sequence Number: 1
• Product Code: LRN
• UDI-Device Identifier: 07611819013841
• UDI-Public: (01)07611819013841
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.62
• Device Lot Number: 42P4943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Date Manufacturer Received: 12/09/2020
• Patient Sequence Number: 1
• Treatment: UNK - DRILL BITS: TRAUMA