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

Model Number	2244-10-000
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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 that the aiming rod was bent and needs to be replaced.No surgical delay.
Additional Manufacturer Narrative
Product complaint # : pc-(b)(4).Investigation summary : the instrument associated with this report was not returned.Depuy-synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Territory (b)(4) reported that the aiming rod was bent and needs to be replaced.No surgical delay.The device associated with this report was not returned for evaluation.The lot that helps determine the age of the device was not available.A search of the complaint database found similar reports and the root cause was attributed to heavy usage and wear out.However, with no instrument returned and no more information, no root cause can be determined for this specific instrument.Based on the investigation, the need for corrective action is not indicated.Complaints will be monitored under post market surveillance (b)(4).Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• 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
• MDR Report Key: 11967350
• Report Number: 1818910-2021-12215
• Device Sequence Number: 19176630
• Product Code: HWT
• UDI-Device Identifier: 10603295107484
• UDI-Public: 10603295107484
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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 Model Number: 2244-10-000
• Device Catalogue Number: 224410000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1