MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 METAGLENE POSITIONER PLATE; EXTREMITY INSTRUMENTS : ALIGNMENT DEVICES

Catalog Number	230787003
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during a case encountered an issue with the metaglene positioning plate.Case was a reverse shoulder replacement using the delta xtend instruments, it damaged two metaglene wires, as it would not pass through the plate cleanly.Troubleshooting conducted ¿ we opened spare glenoid tray with an additional positioning plate and got a 3rd metagene wire, which went through positioning plate cleanly with no obstruction.We then used the 3rd wire on the suspected damaged plate and it did not go through cleanly, suggesting there was an issue with the positioning plate.
Additional Manufacturer Narrative
Product complaint # =(b)(4).Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.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.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.
Event or Problem Description
C.Can you please clarify what you mean by "damaged"? was it worn, cracked, broken into pieces, bent, stripped, threaded, or any device interaction? the hole in the center of the plate did not allow a guide wire to pass through.D.Please clarify the exact allegation against the reported devices.It damaged two metaglene wires, as it would not pass through the plate cleanly.E./were there any adverse consequence/s that affected the patient because of the reported event? none reported.F.Was there a surgical delay? what is the duration of the delay? none reported.
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.H10 additional narrative: added: b5.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: METAGLENE POSITIONER PLATE
• Common Device Name: EXTREMITY INSTRUMENTS : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• 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: 19258274
• Report Number: 1818910-2024-10001
• Device Sequence Number: 17765412
• Product Code: HTZ
• UDI-Device Identifier: 10603295116448
• UDI-Public: 10603295116448
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K170748
• 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): 05/07/2024

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: 230787003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 05/07/2024; 05/13/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 05/08/2024; 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown