MAUDE Adverse Event Report: DePuy Orthopaedics Inc US S-ROM; Orthopedic Manual Surgical Instrument

Catalog Number	530360
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # = > (b)(4) investigation summary = > according to the information provided: "it was reported that t handle would not disengage with reamers".The product was returned to depuy synthes for evaluation, and an investigation was conducted in accordance with depuy synthes procedures.Visual inspection of the returned device found no indication of a device defect. device had signs of usage on its overall surface and it was returned alone, with no mating component connected to its connector/assembly area.No other anomalies were noted.Even though the conditions in which the reported failure cannot be replicated and the mating component was not returned for evaluation, a functional test was performed using a depuy synthes hudson adaptor connector (pn:244000520) sample.The functional test revealed both devices were able to assemble correctly and no sign of undesired movement nor resistance during both assembly and disassembly process.The reported complaint was not confirmed based on the evaluation results.Although no product defect was identified, other circumstances during device use may have contributed to the reported condition, which could not be replicated during laboratory testing.It has been determined that no corrective or preventive actions are proposed.There is no indication that a design or manufacturing issue caused the reported condition.As part of depuy synthes quality processes, all devices are manufactured, inspected, and released in accordance with approved specifications.Additional monitoring for potential safety signals is conducted through complaint trend analysis as part of post-market safety surveillance activities.Device history review = > a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the date code ak1202 provided is not a valid finished goods lot number.Corrected: h3.

• Brand Name: S-ROM
• Common Device Name: Orthopedic Manual Surgical Instrument
• Manufacturer (Section D): DePuy Orthopaedics Inc US; 700 orthopaedic drive; warsaw IN 46581 -098
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; +1(908)386-3534
• MDR Report Key: 50740055
• Report Number: 1818910-2026-15670
• Device Sequence Number: 10633766
• Product Code: LXH
• UDI-Device Identifier: 10603295171546
• UDI-Public: (01)10603295171546(10)AK1202
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• 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: 530360
• Device Lot Number: AK1202
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/16/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/25/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 09/11/2026
• Supplement Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2002
• 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 Age: 76 YR
• Patient Sex: Female
• Patient Weight: 141 LB