MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 LOCKING SCREW 25; SHOULDER IMPLANT - LOCKING SCREW

Model Number 5503-10-025

Device Problem Fracture (1260)

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

Event Date 04/11/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.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 while inserting one of the glenoid locking screws a screw head was broken off.The screw which was a 25mm locking screw and was the anterior screw in the glenoid baseplate.The screw was recessed beneath the baseplate and was subsequently left in the patient and is not expected to cause any issues for the patient moving forward.Doi: (b)(6) 2023 dor: (b)(6) 2023 affected side: right shoulder.

• Brand Name: LOCKING SCREW 25
• Type of Device: SHOULDER IMPLANT - LOCKING SCREW
• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16811254
• MDR Text Key: 313963403
• Report Number: 1818910-2023-08686
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295546580
• UDI-Public: 10603295546580
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212737
• 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
• Report Date: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5503-10-025
• Device Catalogue Number: 550310025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male