MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 KICKSTAND AUGMENT 8; SHOULDER IMPLANT - BASEPLATE

Catalog Number	550708100
Medical Device Problem Codes	Difficult to Insert (1316); Naturally Worn (2988)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Was there any patient harm related to the event? no patient harm due to event.Was there any surgical delay related to the event? yes, there was a 15 minute delay due to event.Is there any patient consequence against the reported product? yes, augment was unable to be used.As a result, surgeon estimated that glenoid coverage was at approximately 80%, thus warranting the need for augmentation that was unfortunately unable to be performed.Was there any allegation with the baseplate/metaglene? no allegation with the baseplate.The central screw and perimeter locking screws that were used went in with no issues and appeared to engage properly.
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.
Event or Problem Description
It was reported that the kickstand augment was unable to be implanted.Surgeon prepared glenoid for a kickstand augment per depuy synthes surgical technique guide, upon attempting to screw in augment, surgeon was unable to engage augment threads with baseplate threads.Apparent cross threading was occurring.Upon two failed attempts with two separate augments, baseplate was then prepared to receive a standard locking screw.Locking screw was able to be inserted with no problems whatsoever, threads were engaged and secure in the baseplate.Surgical delay of 15 minutes occurred days a result of this.Augments will be returned for further evaluation.Unknown surgical delay.Doe: (b)(6) 2024.Affected side: right shoulder.
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 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.
Event or Problem Description
Additional information received states that there was no allegation with the baseplate.The central screw and perimeter locking screws that were used went in with no issues and appeared to engage properly.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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 perform.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: 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: KICKSTAND AUGMENT 8
• Common Device Name: SHOULDER IMPLANT - BASEPLATE
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): NAME PARAGON MEDICAL INC - SMITHFIELD, UT; 125 west 1000 south; smithfield UT 84335
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 20155647
• Report Number: 1818910-2024-18857
• Device Sequence Number: 4236972
• Product Code: PHX
• UDI-Device Identifier: 10603295546955
• UDI-Public: (01)10603295546955(17)280430(10)214968
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K221467
• 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,Followup
• Report Date (Section B): 09/06/2024

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: 550708100
• Device Lot Number: 214968
• 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: 08/27/2024
• Supplement Date Received by Manufacturer: 09/09/2024; 09/17/2024; 10/17/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 09/10/2024; 09/19/2024; 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2023
• 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: KICKSTAND AUGMENT 6; KICKSTAND AUGMENT 8
• Patient Age: 64 YR
• Patient Sex: Male