MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLB SHD END PEG GLEN 44 GBB; SHOULDER GLENOID

Catalog Number 113785045

Device Problems Defective Device (2588); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2023

Event Type  malfunction  

Event Description

It was reported that this was a tsa for na performed on (b)(6) 2023.At a trial, a peg size 44 mm implant trial fitted the affected site, but the real peg size 44 mm implant was unable to be inserted.Therefore, the surgeon exchanged it to a peg size 40 mm implant and inserted it.The surgery was completed successfully with over 30 minutes.There was no harm to the patient.No further information is available.

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.Product code 113785045, lot j9636c was reported by the initial reporter.Follow-up is being conducted in order to determine the associated regulatory information.A supplemental report will be submitted if additional information is received 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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: according to the information provided, "it was reported that this was a tsa for na performed on (b)(6) 2023.At a trial, a peg size 44 mm implant trial fitted the affected site, but the real peg size 44 mm implant was unable to be inserted.Therefore, the surgeon exchanged it to a peg size 40 mm implant and inserted it.The surgery was completed successfully with over 30 minutes.There was no harm to the patient.No further information is available.".The glb shd end peg glen 44 gbb (p/n: 113785045, lot # j9636c) device associated with this report was returned to depuy synthes for evaluation.Visual analysis found deep scratches on the articulating surface of the pegged glenoid as well as gouges found on the inferior edge of glenoid bone interface surface.The damage is consistent with extraction attempts after insertion.The poly surface including all five pegs are free of any surface level defects/burrs that could inhibit the device from being inserted.There is no evidence to suggest the device was unable to be inserted intraoperatively.Dimensional analysis of the overall device and all five pegs was performed.Per drawing dwg-113785045 rev.B, all dimensions measured of the device were found to be within tolerance specifications (see attachment for measurement details).The overall complaint could not be confirmed based on the evidence and information available.The damage on the surface of the device is attributed to user extraction intraoperatively.No further conclusion can be drawn.Based on the investigation findings, no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the 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: a search of the depuy synthes quality system was performed for the finished device lot number j9636c, and no non-conformances or manufacturing irregularities were identified.

• Brand Name: GLB SHD END PEG GLEN 44 GBB
• Type of Device: SHOULDER GLENOID
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18040042
• MDR Text Key: 326977885
• Report Number: 1818910-2023-22043
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 113785045
• Device Lot Number: J9636C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1