MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 HUMERAL IMPLANT DRIVER; EXTREMITY INSTRUMENTS : HANDLES

Model Number 2307-83-000

Device Problems Device-Device Incompatibility (2919); Naturally Worn (2988)

Patient Problem Insufficient Information (4580)

Event Date 04/01/2022

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

Glenoid cannulated stop drill as it was blunt.Humeral implant driver.The connection between the driver and the trial stem/prothesis was loose due to wear and tear.When the surgeon reattached the implant driver to the trial stem (in situ in the patients humerus) it kept pulling off the trial.Surgical delay of 2 minutes occurred.No adverse affects on the patient.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The investigation could not verify or draw any conclusions about the root cause of the reported event without the device to examine.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 : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: d4 (lot), h4.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: HUMERAL IMPLANT DRIVER
• Type of Device: EXTREMITY INSTRUMENTS : HANDLES
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• 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: 14140937
• MDR Text Key: 289494135
• Report Number: 1818910-2022-06944
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295116363
• UDI-Public: 10603295116363
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2307-83-000
• Device Catalogue Number: 230783000
• Device Lot Number: 2501415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2009
• 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