MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET RATCHET SCDR HDL; HIP INSTRUMENTS : HANDLES

Catalog Number	227402000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2025
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.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 during surgery that the screwdriver handle with ratchet was damaged, but still it was possible to solve the issue by screwing directly with the piece in the hand and using a large handle that was inside another instrument, thus achieving to finish the surgery successfully, without affecting the patient and without alterations in the surgical times.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, "the screwdriver handle with ratchet is damaged ref, lot, of the equipment n°, for this novelty the specialist is annoyed, but still it is possible to solve by screwing directly with the piece in the hand and using a large handle that was inside another instrument, thus achieving to finish the surgery successfully, without affecting the patient and without alterations in the surgical times.At the end of the report is left in the case report and this medium in order to report what happened, the handle of screwdriver with ratchet is marked with red tape and is left inside the equipment for easy identification, review and change at the time the devices return to j& j facilities." the product was not returned to medtech orthopaedics, however photos were provided for review.The photo investigation of "227402000, quickset ratchet scdr hdl" revealed that the handpiece has been broken.The observed condition of the device was consistent with a use error that may have been caused by exposure to unintended forces.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the quickset ratchet scdr hdl would contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed to unintended use error 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 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 lot: the device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: QUICKSET RATCHET SCDR HDL
• 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: 22963761
• Report Number: 1818910-2025-15184
• Device Sequence Number: 18455940
• Product Code: HXX
• UDI-Device Identifier: 10603295109020
• UDI-Public: (01)10603295109020
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 227402000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/16/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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