MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ACETABULAR ALIGNMENT GUIDE; HIP INSTRUMENTS : ALIGNMENT DEVICES

Catalog Number	224410000
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
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 medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary the product was returned to depuy synthes for evaluation.Visual analysis of the returned device found that the acetabular alignment guide was stuck from the alignment gauge, preventing free movement of the mechanism.No additional anomalies were identified.Etching on the device indicates regular lubrication to help instrument function smoothly, the potential cause could be attributed to a combination of poor instrument maintenance and wear out.The observed condition could be attributed to maintenance; however, the device was manufactured in 2001, has been in service for over 25 years and shows signs of heavy repeated use.Therefore, the potential cause of failure is traced to end of life.A functional test was unable to be performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the acetabular alignment guide would have contributed to device issues.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 a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the date code (ah1101) provided is not a valid finished goods lot#.
Event or Problem Description
It was reported that the impacted products had an unknown allegation.Event did not happen in surgery.Investigation showed the devices were stuck.

• Brand Name: ACETABULAR ALIGNMENT GUIDE
• Common Device Name: HIP INSTRUMENTS : ALIGNMENT 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: 24916040
• Report Number: 1818910-2026-07087
• Device Sequence Number: 9800149
• Product Code: HWT
• UDI-Device Identifier: 10603295107484
• UDI-Public: (01)10603295107484(10)AH1101
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 224410000
• Device Lot Number: AH1101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2001
• 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