MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 PINN INST CASE W/TRAY AND LID; HIP INSTRUMENTS : INSTRUMENT CASES

Model Number 2217-60-015

Device Problems Peeled/Delaminated (1454); Contamination /Decontamination Problem (2895)

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

Event Date 05/02/2022

Event Type  malfunction  

Event Description

It was reported that trays are being rejected by the hospital due to staining and burning of the aluminum casket.

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.

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 INST CASE W/TRAY AND LID
• Type of Device: HIP INSTRUMENTS : INSTRUMENT CASES
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• 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: 14372730
• MDR Text Key: 291486522
• Report Number: 1818910-2022-08753
• Device Sequence Number: 1
• Product Code: FSM
• UDI-Device Identifier: 10603295099239
• UDI-Public: 10603295099239
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2217-60-015
• Device Catalogue Number: 221760015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2022
• 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