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

Model Number	2307-87-003
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2023
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 during glenoid preparation the surgeon was utilizing the metaglene positioner plate with the metaglene guide pin.The pin was difficult to pass and appeared to be 'catching as it passed through the central hole'.The positioning guide central hole is burred or roughened internally.The pin was able to be passed and the surgery successfully completed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary the device was not returned to depuy synthes for evaluation, however photo(s) were provided for review.Review of the provided photo(s) confirms that central hole is burred, surface shows the signs of wear and scratches.And as per visuals we can assume that device is unable to assemble with pin.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 manufacturing records evaluation (mre) was not performed.

• 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 IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17183008
• Report Number: 1818910-2023-12784
• Device Sequence Number: 15068377
• Product Code: HTZ
• UDI-Device Identifier: 10603295116448
• UDI-Public: 10603295116448
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 06/22/2023

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: 2763153
• 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: 06/06/2023
• Supplement Date Received by Manufacturer: 07/17/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2020
• 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