MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US METAGLENE POSITIONER PLATE; EXTREMITY INSTRUMENTS : ALIGNMENT DEVICES

Model Number	2307-87-003
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that while trying to position the metaglene guide wire on the metaglene, through the positioning plate, the wire got stuck in the plate before it went into the bone and wouldn't proceed to be inserted.The staff changed the metaglene guide wire and the second one went through the positioning plate but reportedly felt tighter than usual.
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 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.H10 additional narrative: added: d9, d10 and h4.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.D4 (lot) and h3.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, ¿on trying to position the metaglene guide wire on the metaglene, through the positioning plate the wire got stuck in the plate before it went into the bone and wouldn¿t proceed to be inserted.? fault of guide wire or ? fault of the positioning plate.The theatre staff changed the metaglene guide wire and the second one went through the positioning plate but reportedly felt tighter than usual.¿ the device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned sample revealed that there was no damage or defects with the metaglene positioner plate.A dimensional inspection was performed for the metaglene positioner plate and met specifications.A functional test was performed the mating device metaglene guide pin dia 2.5mm was assemble with no problem.The overall complaint was unconfirmed as the observed condition of the metaglene positioner plate would not 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 depuy synthes 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: 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.
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.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 is received at a later date, the investigation will be updated as applicable.

• Brand Name: METAGLENE POSITIONER PLATE
• Common Device Name: EXTREMITY INSTRUMENTS : ALIGNMENT DEVICES
• 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 46581-0988 ; 3035526892
• MDR Report Key: 17370892
• Report Number: 1818910-2023-14902
• Device Sequence Number: 3784599
• 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,Followup
• Report Date (Section B): 07/21/2023

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 Model Number: 2307-87-003
• Device Catalogue Number: 230787003
• Device Lot Number: 5388336
• 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: 07/13/2023
• Supplement Date Received by Manufacturer: 07/25/2023; 09/01/2023; 09/20/2023
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 07/26/2023; 09/04/2023; 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2021
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: METAGLENE GUIDE PIN DIA 2.5MM
• Patient Sex: Unknown