MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US RECLAIM ASSEMBLY BODY; RECLAIM INSTRUMENTS : INSERTION DEVICES

Catalog Number	297500600
Medical Device Problem Code	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
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 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, d4 (lot) and h4.Corrected: d4 (udi).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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).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 separate occasions.A total of 4 instruments.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 reclaim assembly body was returned assemble to the reclaim assem upper pull rod.Additionally, the device exhibited an overall worn condition.A functional test was performed and revealed that the mating device is jammed and will no longer spin up and down the threads through the reclaim assembly body.The complaint condition was able to be replicated.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces, such as off axis impactions which could have caused the mating device to be cross-threaded or applied forces before the involved devices are fully threaded.The overall complaint was confirmed as the observed condition of the reclaim assembly body would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to unintended user error.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: added: h4.
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.

• Brand Name: RECLAIM ASSEMBLY BODY
• Common Device Name: RECLAIM INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23392124
• Report Number: 1818910-2025-18332
• Device Sequence Number: 10052691
• Product Code: LXH
• UDI-Device Identifier: 10603295155942
• UDI-Public: (01)10603295155942(10)SO2003234
• 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: 297500600
• Device Lot Number: SO2003234
• 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