MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 GLENOID REAMER BOWTIE L; SHOULDER INSTRUMENT - REAMER

Catalog Number	620560050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2024
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 (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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the tip of the large bowtie glenoid reamer broke while reaming the glenoid.Fragments were generated and were retrieved.The large blazer fused onto the cannulated handle.There was no mishandling of the product before or after assembling the two items.There was about a 20 minute time delay to try to remove the blazer from the cannulated handle.There was no patient harm.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received that "it was reported that the large bowtie glenoid reamer broke while reaming the glenoid.The large blazer fused onto the cannulated handle.There was a delay in case.No harm to patient¿.This complaint involves one (1) device.The product was not returned to medtech orthopedics; however, photos were provided for review.See attachment "(b)(4) device photo ad 12 jan 2025" the photo investigation revealed that ¿620560050, glenoid reamer bowtie l¿ has broken.The observed condition of the device was consistent with a component failure that may have been caused by exposure to unintended forces.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the glenoid reamer bowtie l would contribute to the complained device issue.Based on the investigation findings, glenoid reamer bowtie l was broken because of 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 complaint condition.As part of medtech orthopedics 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.

• Brand Name: GLENOID REAMER BOWTIE L
• Common Device Name: SHOULDER INSTRUMENT - REAMER
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21158356
• Report Number: 1818910-2025-00898
• Device Sequence Number: 20747241
• Product Code: HWR
• UDI-Device Identifier: 10603295539506
• UDI-Public: (01)10603295539506(10)10033
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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

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: 620560050
• Device Lot Number: 10033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2024
• Supplement Date Received by Manufacturer: 01/20/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2021
• 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
• Patient Age: 75 YR
• Patient Sex: Unknown