MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND SCREW LOCK D4.5X30MM; DELTA XTEND IMPLANTS : SCREWS

Model Number 130790030

Device Problem Difficult to Advance (2920)

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

Event Date 03/23/2022

Event Type  malfunction  

Event Description

It was reported that the locking nut from screw would not seat back in screw.Screw discarded post case.

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.

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.

Event Description

Additional information received indicated that there were no patient consequences.

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 (nc search) was performed for the finished device product code: 130790030, lot - number : 5381946, and no non-conformances / manufacturing irregularities were identified.

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.

Event Description

Additional information received: a.Was surgery time extended due to a depuy synthes product? if yes, how long? surgery was delayed 2 minutes while new screw was opened.Fragments not generated.Surgery time extended 2 mins.B.Please confirm if this event happened during primary surgery or revision surgery? if revision surgery please provide reason for revision and all explanted implants.This was a primary surgery.C.What is the affected side involved in this event? left or right? cannot recall the effected side; my recollection is a right side but this could be incorrect.

• Brand Name: DXTEND SCREW LOCK D4.5X30MM
• Type of Device: DELTA XTEND IMPLANTS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• 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: 14042639
• MDR Text Key: 288793420
• Report Number: 1818910-2022-06329
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 10603295027843
• UDI-Public: 10603295027843
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K120174
• 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,Followup
• Report Date: 04/07/2022

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 Model Number: 130790030
• Device Catalogue Number: 130790030
• Device Lot Number: 5381946
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2022
• Initial Date FDA Received: 04/07/2022
• Supplement Dates Manufacturer Received: 05/05/2022; 05/12/2022; 05/17/2022
• Supplement Dates FDA Received: 05/11/2022; 05/13/2022; 05/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2021
• 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