MAUDE Adverse Event Report: SYNTHES GMBH GUIDE WIRE 3.2MM FOR PFNA BLADE; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	356.830
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on an unknown date, the nail broke postoperatively.Upon return of products to the manufacturer, it was discovered that additional items were deformed and/or broken.This product complaint captures the first broken nail and is related to (b)(4), which captures the second broken nail.
Additional 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: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found fragments near the fluted tip were delaminated off; it seems they were cut off by another tool.The device was also found bent.The observed condition of the device was consistent with a component failure that was caused by exposure to unintended forces most likely with other tools or hard edges that came in contact with the device.Properly handling and attention to the approved use of the device diminishes the risk of failure.A dimensional inspection was unable to be performed due to the post-manufacturing damage.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the guidewire ø3.2 f/pfna blade would have contributed to the complained device issue.Based on the investigation findings it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : part: 356.830, lot: 523p226, manufacturing site: balsthal, release to warehouse: 16-dec-2021.A dhr evaluation was performed for the finished device article # 356.830 lot # 523p226, and no non-conformances were identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: GUIDE WIRE 3.2MM FOR PFNA BLADE
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 20224679
• Report Number: 8030965-2024-11512
• Device Sequence Number: 3469478
• Product Code: FZX
• UDI-Device Identifier: 07611819291355
• UDI-Public: (01)07611819291355(10)523P226
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 356.830
• Device Lot Number: 523P226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE Ø3.2 F/PFNA BLADE; GUIDEWIRE Ø3.2 F/PFNA-II BLADE; LOCKSCR Ø5 L42 F/NAILS TAN LIGHT GREEN; LOCKSCR Ø5 L44 F/NAILS TAN LIGHT GREEN; TFNA FEM NAIL Ø12 LE 130° L235 TIMO15; TFNA HELICAL BLADE PERF L90 TAN; TFNA HELICAL BLADE PERF L95 TAN; UNK - NAILS: TFNA
• Patient Sex: Unknown