MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 DXTEND SCREW LOCK D4.5X42MM; DELTA XTEND IMPLANTS : SCREWS

Catalog Number 130790042

Device Problems Fracture (1260); Device-Device Incompatibility (2919)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/09/2024

Event Type  malfunction  

Event Description

It was reported that the delta xtend locking screw 42mm item became stuck on insertion.It could not be advanced or removed.Resulting in the head of the screw breaking off the threaded body.Reverse shoulder surgery was delayed 30 minutes due to the reported event.Fragments generated were removed easily without additional intervention.

Manufacturer Narrative

Product complaint (b)(4).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.

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.H6: (clinical and device codes).

Event Description

Additional information received.A.Was there any patient harm relevant to this event? if yes, please kindly provide details.No patient harm, during this event.B.Did it break into two or more pieces? if no, please specify, the alleged deficiency of the instruments.Were they bent, stripped, cross-threaded, etc.? yes the head of the screw broke off the shaft.2 pieces.C.Did the event occur, during primary or revision surgery? primary surgery.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not performed.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 : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

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 that 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

Was there any surgical site infection due to the delay of 30 minutes? no.What's the most recent patient outcome ? no negative outcome.

• Brand Name: DXTEND SCREW LOCK D4.5X42MM
• Type of Device: DELTA XTEND IMPLANTS : SCREWS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19123890
• MDR Text Key: 340352134
• Report Number: 1818910-2024-08465
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027867
• UDI-Public: 10603295027867
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup,Followup
• Report Date: 04/17/2024

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 Catalogue Number: 130790042
• Device Lot Number: 5416047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/17/2024
• Supplement Dates Manufacturer Received: 04/17/2024; 04/25/2024; 04/29/2024
• Supplement Dates FDA Received: 04/20/2024; 04/27/2024; 05/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2022
• 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