MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND SCREW LOCK D4.5X36MM; JRN : SCREWS

Catalog Number 130790036

Device Problems Fracture (1260); Difficult to Advance (2920)

Patient Problem Insufficient Information (4580)

Event Date 11/13/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint (b)(4).H4- unable to determine product manufacturing date based on the provided lot number.Continued follow-up is being conducted and any additional information received will be reported.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.

Event Description

It was reported that the central screw on glenosphere broke and dislocated from implant construct.It was replaced , as well as, one of the screws and the poly.The glenosphere was dislocated from the implant construct.Glenosphere was replaced, as was one of the screws and the poly.Doi: (b)(6) 2019.Dor: november 13, 2023.Affected side: right shoulder.

Event Description

Additional information received: a.Please clarify, was the glenosphere fractured? no.B.Was there any suggestion by anyone indicating that there was or may be a deficiency with the dxtend screw lock d4.5x36mm? if yes, please provide details: possibly wasn't seated all the way.

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A manufacturing record evaluation (nc search) was performed for the finished device product code:130790036, lot - 5329003 and no non-conformances / manufacturing irregularities were identified.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: a manufacturing record evaluation (nc search) was performed for the finished device product code:130790036, lot - 5329003 and no non-conformances / manufacturing irregularities were identified.

• Brand Name: DXTEND SCREW LOCK D4.5X36MM
• Type of Device: JRN : SCREWS
• 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 46581 ; 3035526892
• MDR Report Key: 18215636
• MDR Text Key: 329106711
• Report Number: 1818910-2023-24073
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027850
• UDI-Public: 10603295027850
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192855
• 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,Followup,Followup
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 130790036
• Device Lot Number: 5329003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2018
• 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
• Treatment: DXTEND GLENOSPHERE ECC D42MM; DXTEND STAND PE CUP D42 +6MM
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male