MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 AUG CTR SCREW META FULL WEDGE; SHOULDER IMPLANT - METAGLENE

Catalog Number	130970850
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 upon screwing the glenosphere into the collet and metaglene, the surgeon got the tactile feel that the screw would tighten and then once it reached a certain tightness would release and feel as if not threaded at all.Surgical delay unknown.Doe: on (b)(6) 2023.Affected side: unknown shoulder.
Event or Problem Description
Additional information received: a.Was there any surgical delay? if yes, what is the duration of the delay? -no.B.Was/were there any patient consequence/s related to the event? -no.C.Please confirm the event date.-event date noted as date implanted.
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.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).Investigation summary : no device associated with this report was received for examination.Dhr review: a manufacturing record evaluation was performed for the finished device product code - 130970850, lot number - 4263394 , and no non-conformances / manufacturing irregularities were identified.Product code 130970850, work order (b)(4) was manufactured on 22-aug-2023.(b)(4) parts were manufactured per specification and all raw materials met specification.Scrap: 1 part of this lot was scrapped: scrap code a1299: this concerns meta op20 ctq17.There is no correlation between this scrap reason and the failure mode of the complaint reprocessing: there was no material reprocessing reports (mrr) associated with this lot.Non-conformance: there were no non-conformances associated with this lot.Coc review certificate of conformance review for 25 parts, product code 100042500, work order (b)(4) did meet specification.Complaint confirmation: non-verifiable.Conclusion: due to no similar failures found in the dhr review, the root cause of the complaint cannot be determined.Should further information become available that impacts the findings in this investigation it will be reopened.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 : a manufacturing record evaluation was performed for the finished device product code - 130970850, lot number - 4263394 , and no non-conformances / manufacturing irregularities were identified.

• Brand Name: AUG CTR SCREW META FULL WEDGE
• Common Device Name: SHOULDER IMPLANT - METAGLENE
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18118379
• Report Number: 1818910-2023-23021
• Device Sequence Number: 20587113
• Product Code: PHX
• UDI-Device Identifier: 10603295525332
• UDI-Public: 10603295525332
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K203694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/13/2023

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 Catalogue Number: 130970850
• Device Lot Number: 4263394
• 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: 11/02/2023
• Supplement Date Received by Manufacturer: 11/22/2023; 12/13/2023
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 12/01/2023; 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CTR SCREW METAGLENE COLLET.; UNKNOWN BONE CEMENT.; XTNDGLENO D38MM +0MM SHRTPST.
• Patient Sex: Unknown