MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLO ADV RATCHET T-HANDLE; EXTREMITY INSTRUMENTS : HANDLES

Model Number 2128-61-070

Device Problems Crack (1135); Contamination /Decontamination Problem (2895)

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

Event Date 05/23/2022

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

It was reported that after the pans went through the wash, it was notified by spd that the rubber on the t-handle was ripped and that they could no longer use it.The t-handle is still useable but they are unable to clean it and keep it sterile.No surgical delay.

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: GLO ADV RATCHET T-HANDLE
• Type of Device: EXTREMITY INSTRUMENTS : HANDLES
• 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 46580 ; 3035526892
• MDR Report Key: 14647329
• MDR Text Key: 295784748
• Report Number: 1818910-2022-10557
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295089728
• UDI-Public: 10603295089728
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2128-61-070
• Device Catalogue Number: 212861070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2022
• 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