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

Catalog Number	130770030
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that intraoperatively a non-locking screw fractured during screwing into the metaglene.It was not possible to remove the fragment; removing it would have caused too much harm.Another hole was used to insert another screw.
Additional 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.
Additional 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 or Problem Description
Additional information received: a.Was there any surgical delay related to the event? if yes, what is the duration of the delay? the delay did not last long - 3-4 minutes at most.B.Was there any patient harm/consequence related to the event? we left the fractured screw in the patient, as otherwise the damage would have been extensive.However, it should not affect the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, ¿intraoperatively a non-locking screw fractured during screwing into the metaglene.It was not possible to remove the fragment; removing it would have caused too much harm.Another hole was used to insert another screw.¿.The product returned to medtech orthopaedics for evaluation.The medtech orthopaedics team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that dxtend screw no lock d4.5x30mm has fractured across the neck, between the head and the threaded shaft.Only the fragment from the screw head was returned for evaluation; however, there was no evidence that the other broken fragment was left in patient.The fracture surface exhibits characteristics consistent of torsional overload.No evidence of material or manufacturing defects were observed.Therefore, further material analysis activities beyond visual analysis were not performed.A dimensional inspection was unable to be performed due to post manufacturing damage.With the available information is not possible to determine a potential cause at this moment.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences during surgical process.A manufacturing record evaluation was performed for the finished device [130770030 / 5424763] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The overall complaint was confirmed as the observed condition of the dxtend screw no lock d4.5x30mm would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: 1) quantity manufactured: (b)(4); 2) date of manufacture: 6-jan-2023; 3) any anomalies or deviations identified in dhr: none; 4) expiry date: 31-dec-2027; 5) ifu reference: (b)(4).Device history review: a manufacturing record evaluation was performed for the finished device [130770030 / 5424763] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.

• Brand Name: DXTEND SCREW NO LOCK D4.5X30MM
• Common Device Name: 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 46582
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19749242
• Report Number: 1818910-2024-15196
• Device Sequence Number: 9145196
• Product Code: HSD
• UDI-Device Identifier: 10603295027805
• UDI-Public: (01)10603295027805(17)271231(10)5424763
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K192855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 130770030
• Device Lot Number: 5424763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2024
• Supplement Date Received by Manufacturer: 07/29/2024; 10/04/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 07/30/2024; 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown