MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 36MM PINN AB IN TR 56; HIP INSTRUMENTS : ACETABULAR TRIALS

Model Number	2218-87-356
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Hip revision: the surgeon was trialing with the ab 56/36mm trial into the gription acetabular cup (relocated and took the leg through a rom), and when they removed the trial from the acetabulum they noticed it had come apart on the mayo table.Saline was used in the patient with suction to clean any debris.Surgeon was happy.Was surgery delayed due to the reported event? no.Was procedure successfully completed? yes.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: the device associated with this report was not returned for analysis.Review of the photographic evidence confirmed the reported allegation.The snap ring was found broken, no other defects were observed on the device.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing records evaluation (mre) was not performed as no valid finished good lot number was provided for this device.

• Brand Name: 36MM PINN AB IN TR 56
• Common Device Name: HIP INSTRUMENTS : ACETABULAR TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15962170
• Report Number: 1818910-2022-25117
• Device Sequence Number: 5668851
• Product Code: HWT
• UDI-Device Identifier: 10603295101932
• UDI-Public: 10603295101932
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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
• Report Date (Section B): 12/12/2022

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: 2218-87-356
• Device Catalogue Number: 221887356
• Device Lot Number: BF1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2022
• Supplement Date Received by Manufacturer: 01/23/2023; 02/03/2023
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 01/26/2023; 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2001
• 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 Age: 49 YR
• Patient Sex: Male