MAUDE Adverse Event Report: DEPUY IRELAND 9616671 DXTEND SCREW NO LOCK D4.5X30MM; DELTA XTEND IMPLANTS : SCREWS

Model Number 130770030

Device Problem Fracture (1260)

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

Event Date 03/13/2023

Event Type  malfunction  

Event Description

It was reported that one of the non locking screws¿ head broke off while screwing onto the metaglene.The screw was still progressing while the head of the screw just twisted off.The screw was left in the patient and the head of the screw i will send back.There was no damage to the patient, any additional blood loss or time added to the procedure.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary - the device associated with this report was not returned to depuy synthes for evaluation.Review of the photographic evidence was able to confirm that the screw has fractured, only the head is visible on the photo attached.However, no evidence of the implant fragment left in patient was provided.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot - a manufacturing record evaluation was performed for the finished device [(b)(4)] number, and no non-conformances / manufacturing irregularities were identified.Device history review - a manufacturing record evaluation was performed for the finished device [(b)(4)] number, and no non-conformances / manufacturing irregularities were identified.

• Brand Name: DXTEND SCREW NO LOCK D4.5X30MM
• Type of Device: DELTA XTEND IMPLANTS : SCREWS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16626864
• MDR Text Key: 312112501
• Report Number: 1818910-2023-06671
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027805
• UDI-Public: 10603295027805
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K192855
• 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: 03/28/2023

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 Expiration Date: 05/31/2023
• Device Model Number: 130770030
• Device Catalogue Number: 130770030
• Device Lot Number: 5317093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2023
• Initial Date FDA Received: 03/28/2023
• Supplement Dates Manufacturer Received: 05/25/2023
• Supplement Dates FDA Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2018
• 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