MAUDE Adverse Event Report: SYNTHES GMBH SYNFRAME GUIDE ROD W/ADJUST-CLAMP F/SOFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	387.358
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, it was noted four items from the synframe set were damaged/longer working.There were no patient consequences.It was noted the devices were worn, stripped and cross threaded.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.
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: d9.Corrected: d4 (lot, primary udi number).H3, h6: the device was 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.
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: h3, h6: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device revealed that the screw securing the clamp of the synframe guide rod w/adjust-clamp f/soft was found jammed in the internal threads of the guiding component.Therefore, the clamp cannot be opened or closed.No sings of breakage was observed on the device.However, the reported condition can be confirmed.The observed condition of the device is consistent with a component failure that was caused by exposure to unintended forces like overtightening the device while assemblance; or by assembling the device in a misaligned position.Properly handling and attention to the approved use of the device diminishes the risk of failure.According to the surgical technique, loosen the setscrew in the adjustable clamp of the guide rod with socket wrench 6.0 mm, the adjustable tip fo the affixed retractor can then be pivoted on its axis, and the visible working area can be enlarged.Warning: if the socket wrench is used as a lever, there is a danger of too much force being transmitted to the retractor.This can damage the retracted structures.It is therefore, recommendable to guide the moveable retractor with your finger.The tension can be adjusted and distributed safely for soft tissue.A dimensional inspection was not performed as it is not applicable to the complaint condition.A functional test was performed and the device could rotate 90 degrees.However, the screw couldn't be loosened or tightened due to it was jammed.The overall complaint was confirmed as the observed condition of the synframe guide rod w/adjust-clamp f/soft 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 review: part: 387.358.Synthes lot: 2564416.Supplier lot: 2564416.Release to warehouse date: mar 10, 2010.Manufactured by: synthes gmbh oberdorf.No 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SYNFRAME GUIDE ROD W/ADJUST-CLAMP F/SOFT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 21805981
• Report Number: 8030965-2025-03432
• Device Sequence Number: 12589276
• Product Code: LXH
• UDI-Device Identifier: 07611819099005
• UDI-Public: (01)07611819099005(10)2564416
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other Health Care Professional
• 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: 387.358
• Device Lot Number: 2564416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/17/2025
• Supplement Date Received by Manufacturer: 04/24/2025; 05/13/2025
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 04/28/2025; 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2021
• 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
• Patient Sex: Unknown