MAUDE Adverse Event Report: SYNTHES GMBH WIRE GUIDE / MULTIHOLE / LONG FOR NAILS Ø 8-11MM; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	03.043.005
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that when doing a suprapatellar nail, the surgeon attempted to put in the 3.2 guide through the wire guide, and it was catching.It would not slide smoothly.It was catching and so it do not hold intensity because he slid it through the other hole and was able to adapt, but it was faulty at this point.It did not hold up surgery nor did it affect patient outcome.
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.H11 additional narrative: corrected: h4.The product was not returned to medtech orthopaedics, however photos were provided for review.The photo investigation of "03.043.005, wire guide / multihole / lg nl 8-11" can not revealed the reported condition.As, the evidence provided was not sufficient to confirm the reported event of unable to assemble and disassemble.Functionality issues cannot be evaluated through photo investigation.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the observed condition of the wire guide / multihole / lg nl 8-11 would not contribute 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 complaint condition.As part of 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 review: part number: 03.043.005-us, lot number: 820p931, manufacturing site: hägendorf, release to warehouse date: 25-may-2022.A manufacturing record evaluation was performed for the finished device batch number, 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.
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.H11 additional narrative: added: a2 (age).H3, h4, h6: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the proximal hole of the wire guide / multihole / lg nl 8-11 was slightly deformed.The observed condition of the device is consistent with a component failure that was caused by exposure to unintended forces like assembling the device in a misaligned position.Properly handling and attention to the approved use of the device diminishes the risk of failure.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not able to be performed due to the mating device was not returned for evaluation.However, the customer allegation can be substantiated due to the damage observed on the device.The overall complaint was confirmed as the observed condition of the wire guide / multihole / lg nl 8-11 would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to component failure, and 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 review (dhr): part number: 03.043.005-us, lot number: 820p931, manufacturing site: hägendorf, release to warehouse date: 25-may-2022.A manufacturing record evaluation was performed for the finished device batch number, 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: WIRE GUIDE / MULTIHOLE / LONG FOR NAILS Ø 8-11MM
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22497107
• Report Number: 8030965-2025-07111
• Device Sequence Number: 8459063
• Product Code: FZX
• UDI-Device Identifier: 10886982297150
• UDI-Public: (01)10886982297150(10)820P931
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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: 03.043.005
• Device Lot Number: 820P931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/27/2025
• Supplement Date Received by Manufacturer: 07/24/2025; 07/31/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 07/28/2025; 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2022
• 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
• Patient Age: 76 YR
• Patient Sex: Female