MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN POLY EXTRACTOR; HIP INSTRUMENTS : EXTRACTION INSTRUMENTS

Model Number 2217-50-001

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2022

Event Type  malfunction  

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 Description

During pre-operative inspection, operating room staff, noticed that the ard pin on a pinnacle polyethylene extractor was bent and unusable.No surgical delay.No patient consequence.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device was received for examination; therefore, the reported event could not be confirmed.Depuy considers the investigation closed.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: PINN POLY EXTRACTOR
• Type of Device: HIP INSTRUMENTS : EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14336929
• MDR Text Key: 291212772
• Report Number: 1818910-2022-08459
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295098928
• UDI-Public: 10603295098928
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2022

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
• Device Operator: Health Professional
• Device Model Number: 2217-50-001
• Device Catalogue Number: 221750001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2022
• Initial Date FDA Received: 05/09/2022
• Supplement Dates Manufacturer Received: 05/25/2022
• Supplement Dates FDA Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1