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

Catalog Number	620010002
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
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.Corrected: d4 (primary udi #).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 : 1.Locking screw broke when inserter 2.Locking screw kept going through baseplate when inserted.3.Pin cold welded into cut guide when using divergent pin.The product was returned to depuy synthes for evaluation.Visual investigation of the returned device found a pin was stuck through the left divergent pin hole at the silhouette resection guide.The observed condition was consistent with the pin being drilled into the left divergent pinhole in an misaligned position.A functional test was performed and was not able to disengage the devices.A dimensional inspection was performed not performed since it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the silhouette resection guide would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to unintended use 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 : 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.Added: h4 corrected: h3.
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.
Event or Problem Description
It was reported that the pin cold welded into cut guide when using divergent pin.

• Brand Name: SILHOUETTE RESECTION GUIDE
• Common Device Name: 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: 19575292
• Report Number: 1818910-2024-13406
• Device Sequence Number: 8410260
• Product Code: MBF
• UDI-Device Identifier: 10603295538974
• UDI-Public: (01)10603295538974(10)659916
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K202716
• 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,Followup
• Report Date (Section B): 06/20/2024

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: 620010002
• Device Lot Number: 659916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/10/2024
• Supplement Date Received by Manufacturer: 07/11/2024; 07/18/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 07/15/2024; 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LCS COMP RP INSERT LG 10MM; MODULAR UNITI BASEPLATE S 24; UNKNOWN SHOULDER LOCKING SCREW
• Patient Sex: Unknown