MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 SILHOUETTE RESECTION GUIDE; SHOULDER INSTRUMENT - RESECTION GUIDE

Catalog Number 620010002

Device Problem Material Deformation (2976)

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

Event Date 01/01/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).B3: date of event is an unknown date in 2023.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 Description

The instruments were reported for an unknown reason.The event did not occur during surgery.Update per investigational findings after visual inspection on 09/14/2023, the following was found: silhouette resection guide was found deformed and dented at the divergent pin holes.Glenosphere inserter tip were found stripped at the tip.Baseplate inserter rod were found striped at the tip and unable to assemble with the mating device.

Manufacturer Narrative

Product complaint #
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> (b)(4).Investigation summary
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> the instruments were reported for an unknown reason.The event did not occurred during surgery.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned sample revealed that edges of two divergent pin holes of the silhouette resection guide (620010002 / 176265) were found deformed and dented in both sides of the device.The observed condition of the device consistent with the pin being drilled into the right divergent pin hole in an misaligned position.The overall complaint was unconfirmed as the observed condition of the silhouette resection guide would not contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to unintended user error and 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
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> 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.H3.

• Brand Name: SILHOUETTE RESECTION GUIDE
• Type of Device: SHOULDER INSTRUMENT - RESECTION GUIDE
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• 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: 17775395
• MDR Text Key: 323753512
• Report Number: 1818910-2023-19073
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 620010002
• Device Lot Number: 176265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1