MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENTERING; HIP INSTRUMENTS : HANDLES

Catalog Number	205512000
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
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.H11 additional manufacturer narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
It was reported that s/c trial handle and s/c trial handle angled were due to an inability to disassemble the instruments, which prevented cleaning behind the spring balls.The event was identified in the central sterile services department, and the customer declined to reprocess the instruments.There was no adverse patient impact or surgical delay associated with this event.
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 that 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: d4 (lot), d9, h4.Corrected: d4 (primary udi number).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).Investigation summary according to the information received, "customer´s cssd is not willing to reprocess the instruments.They are not able to clean the instrument behind the spring balls and it is not possible to disassemble the instruments.No adverse patient impact, no surgical delay.Seen in cssd." the product was returned to depuy synthes for evaluation.Visual analysis of the returned device revealed that the s/c trial handle was received in a disassembled condition.Nevertheless, even under this condition, it is possible to confirm the reported event based on the findings observed during the inspection.The presence of foreign material accumulated behind two of the four ball plungers was identified, which confirms the issue upon disassembly of the device.Per ifu-0902-00-721, care should be taken to remove any debris, tissue, or bone fragments that may collect on the instrument.Instruments with cannulas, moving parts, or spring mechanisms require additional cleaning steps to ensure proper removal of all trapped debris.In addition to other important steps to follow, the ifu instructs the use of a soft bristle brush to remove all traces of blood and debris, paying close attention to threads, crevices, seams, and any hard-to-reach areas of the device features.If the instrument has sliding mechanisms or hinged joints, actuate the area to free any trapped blood and debris.A functional test was performed using a laboratory sample mating device, and the device was not able to be assembled or disassembled properly.Potential cause can be traced to a component failure, caused by the accumulation of debris behind the ball plungers, preventing proper device function.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 s/c trial handle would have contributed to the complained 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 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 1) quantity manufactured: 50 pcs 2) date of manufacture: 5/19/2022 3) any anomalies or deviations identified in dhr: none 4) expiry date: n/a 5) ifu reference: 090200721, rev l device history batch null device history review a manufacturing record evaluation was performed for the finished device product code 205512000 lot number pg319550, and no non-conformances / manufacturing irregularities were identified during manufacturing.Corrected: h3.

• Brand Name: SELF CENTERING
• Common Device Name: HIP INSTRUMENTS : HANDLES
• 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: 24400162
• Report Number: 1818910-2026-03351
• Device Sequence Number: 15981014
• Product Code: LXH
• UDI-Device Identifier: 10603295084471
• UDI-Public: (01)10603295084471(10)PG319550
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,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: 205512000
• Device Lot Number: PG319550
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 03/02/2026; 04/20/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/05/2026; 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2022
• 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 Sex: Unknown