MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 DXTEND SCREW LOCK D4.5X30MM; DELTA XTEND IMPLANTS : SCREWS

Model Number 130790030

Device Problem Fracture (1260)

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

Event Date 01/19/2023

Event Type  malfunction  

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, a follow-up will be filed as appropriate.

Event Description

It was reported that this was an rsa performed on (b)(6) 2023.When the surgeon was inserting the 4.5mm×30 locking screw into the anterior of a metaglene, the head of it broke.Therefore, the surgeon tried to use the 4.5mm×24mm locking screw, but it also broke like the first one.The surgeon judged that the fixation was adequate because superior, inferior, and posterior screws were inserted firmly.The surgeon decided not to insert a locking screw into the anterior.The surgeon assumes that the locking screws got broken because the patient¿s bone quality was good/hard.There was no surgical delay and no harm to the patient.No further information is available.

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.Device history lot: a manufacturing record evaluation was performed for the finished device (b)(6) , lot 5412990 and no non-conformances / manufacturing irregularities were identified.

• Brand Name: DXTEND SCREW LOCK D4.5X30MM
• Type of Device: DELTA XTEND IMPLANTS : SCREWS
• 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: 16271597
• MDR Text Key: 308472871
• Report Number: 1818910-2023-02449
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027843
• UDI-Public: 10603295027843
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 130790030
• Device Catalogue Number: 130790030
• Device Lot Number: 5412990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2023
• 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: Unknown
• Patient Sequence Number: 1