MAUDE Adverse Event Report: SYNTHES GMBH 2.5MM WIRE GUIDE FOR 5.0MM SCREWS; GUIDE, SURGICAL, INSTRUMENT

Catalog Number 324.174

Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981)

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

Event Date 01/11/2023

Event Type  malfunction  

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10: additional narrative: h6: part: 324.174.Synthes lot: 5413759.Supplier lot: n/a.Release to warehouse date: 15 january 2007.Manufactured by: synthes brandywine.No nonconformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that wire guide 5 f/guidewire ø2.5 had worn condition observed at the threads.The observed condition was consistent as an end of life indicator for the device.No other issues were identified.It is reasonable to conclude that the worn condition would make the device unable to assemble appropriately.The device exhibits damage consistent with repeated use.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed worn condition of wire guide 5 f/guidewire ø2.5 would have contributed to the complained issue.There is no indication that a design or manufacturing issue has caused the complaint condition.It was determined that the reusable instrument was worn from repeated use and servicing.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Drawing/specifications reviewed: 2.5mm wire guide (current and manufactured).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 columbia reports an event as follows: it was reported that during a procedure on (b)(6) 2023, the guidewire threads are worn and it was difficult to thread into the plate.Quantity of device was determined upon return for manufacturer investigation.Upon investigation, it was determined that one guidewire had a worn condition observed at the threads.This report is for a 2.5mm wire guide for 5.0mm screws.This is report 2 of 2 for (b)(4).

• Brand Name: 2.5MM WIRE GUIDE FOR 5.0MM SCREWS
• Type of Device: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17690215
• MDR Text Key: 322726049
• Report Number: 8030965-2023-11171
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 07611819755192
• UDI-Public: (01)07611819755192
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 324.174
• Device Lot Number: 5413759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: WIRE GUIDE 5 F/GUIDEWIRE Ø2.5