MAUDE Adverse Event Report: 2.5MM DHS/DCS GUIDE WIRE W/THREADED TIP 230MM

Catalog Number 338.000

Device Problems Break (1069); Scratched Material (3020)

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

Event Date 08/25/2021

Event Type  malfunction  

Manufacturer Narrative

Device is not distributed in the united states, but is similar to device marketed in the usa.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 (b)(4) reports an event as follows: it was reported the k-wire showed signs of scratches in the surface after use in a non-synthes power tool device.When cleaning the non-synthes power tool device the sterile department observed small metal-dust in the non-synthes power tool device.This report is for a k-wire.This is report 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.H3, h4, h6: product code: 338.000, lot num: 151p705, manufacturing site: balsthal, released to warehouse : 01.June.2021.A manufacturing record evaluation was performed for the finished device 338.000 lot 151p705, and no non-conformances were identified.Visual inspection: the dhs/dcs-guidewire ø2.5 w/thread-tip w/tr (part #: 338.000, lot #: 151p705) was received at us customer quality (cq).Upon visual inspection, the device has scratches all over the shaft.No other defect was observed.Document/specification review: current and manufactured was reviewed.No design issues or discrepancies were identified.Dimensional inspection: measured dimensions shaft od = conform conclusion: this complaint is confirmed as the complaint device was found to have surface scratches.The device was not broken hence this failure mode could not be confirmed.No root cause could definitively be determined for the reported complaint condition.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive 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.

• Brand Name: 2.5MM DHS/DCS GUIDE WIRE W/THREADED TIP 230MM
• Type of Device: GUIDE
• MDR Report Key: 12518993
• MDR Text Key: 272898845
• Report Number: 8030965-2021-07944
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 07611819021907
• UDI-Public: (01)07611819021907
• 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: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 338.000
• Device Lot Number: 151P705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Date Manufacturer Received: 10/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1