MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ENDURANCE STEM INSERTER; HIP INSTRUMENTS : INSERTION DEVICES

Model Number	2521-00-502
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 tip is bent.No surgical delay.
Additional Manufacturer Narrative
Product complaint # = > (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.Device history lot = > a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: ENDURANCE STEM INSERTER
• Common Device Name: HIP INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12300346
• Report Number: 1818910-2021-17485
• Device Sequence Number: 4991572
• Product Code: HWR
• UDI-Device Identifier: 10603295127796
• UDI-Public: 10603295127796
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 07/29/2021

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: 2521-00-502
• Device Catalogue Number: 252100502
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1