MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 RECLAIM BOLT TORQ WRENCH HNDL; WRENCHES

Catalog Number	297500300
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
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.Additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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 four (4) instruments broke during a procedure.Case went smoothly and then when the reporter went to clean up, reporter had 2 instruments cold welded 2 each other in 2 separate occasions.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees hat the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: b5 and d4 (lot).Corrected: d3, d4 (udi) and h6 (medical device problem code).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
Additional information received states that nothing broke specifically, just stuck together.Instruments cannot be used if not taken a part so they were taken out of the rotation.
Additional Manufacturer Narrative
Product complaint #(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint recon described in this report.H11 additional narrative: added: d9.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: it was reported that the reporter had 4 instruments break during a procedure, case went smoothly and then when the reporter went to clean up, reporter had 2 instruments cold welded 2 each other in 2 seperate occassions.A total of 4 instruments.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that the reclaim pronged stem stblzr is attached to the reclaim bolt torq wrench hndl however no signs of a device nonconformance were observed that would contribute to the reported allegation.Functional testing was able to replicate the reported complaint condition.An excessive amount of force was applied to the reclaim bolt torq wrench hndl, however the component was not able to disassemble as intended.Contributing factors of the observed condition of the device include damage due to overtightening the reclaim bolt torq wrench hndl.However, with the available information and due to the jammed condition, a potential cause remains undetermined.Furthermore the "reclaim modular revision hip system surgical technique" give the following recommendation annotations on page 24: the bolt torque wrench must be used to reduce the risk of improper locking bolt assembly tightening.Connect the torque wrench t-handle to the torque wrench body via the square connection.Attach the torque wrench assembly to the implant construct by placing the fork of the torque wrench body over the neck of the proximal body implant.Ensure that the distal end of the torque wrench assembly engages the head of the bolt.To tighten the bolt, turn the t-handle of the torque wrench assembly clockwise until the t-handle clicks.This ensures that the appropriate torque has been applied, and the locking bolt assembly has been fully seated.Remove all instruments and impact the desired femoral head prior to reducing the hip and closing the surgical site.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the reclaim bolt torq wrench hndl would have contributed to the complained issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is required.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes 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 the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.H11 additional narrative: corrected: h4.

• Brand Name: RECLAIM BOLT TORQ WRENCH HNDL
• Common Device Name: WRENCHES
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork IN ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23392079
• Report Number: 1818910-2025-18329
• Device Sequence Number: 9979032
• Product Code: HXC
• UDI-Device Identifier: 10603295155898
• UDI-Public: (01)10603295155898(10)SO2002377
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: 297500300
• Device Lot Number: SO2002377
• 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: 10/07/2025
• Supplement Date Received by Manufacturer: 10/27/2025; 10/28/2025; 12/04/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 10/29/2025; 11/03/2025; 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2001
• 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