MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 MI CALCAR REAMER SHAFT; HIP INSTRUMENTS : REAMERS

Catalog Number	257004500
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the calcar planing tool is blunt and requires replacement.
Event or Problem Description
Additional information was received: 1.What was the exact allegation against the device? was it worn, cracked, broken into pieces, bent, stripped, cross-threaded, or any device interaction? blunt.No longer fit for purpose.2.Was there a surgical delay? if yes, what is the duration of the delay? no delay, another tray is available, and a second instrument is used (fortunately).3.Was there any adverse consequences that affected the patient because of the reported event? no adverse event or reaction to the patient.It was also mentioned that the consignment instrument will need replacing.Tagged as damaged to be returned after decontamination is completed.
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.H10 additional narrative: added: b5.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d1, d2a, d2b, d4 (lot, catalog, udi).
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: photographs were provided but they do not represent the current complaint condition or a device malfunction, example; photos of tags, photos of sticker sheets (and the allegation is unrelated to labeling), unrelated photos, etc.According to the information received, ¿surgeon requested that the calcar planing tool is blunt and requires replacement from the consignment set." the product was not returned to depuy synthes, however photos were provided for review.See attachment ¿a-10985181 source data¿.The photographs attached were reviewed, however they do not represent the reported complaint condition.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the photographs provided are not representative of the reported complaint condition.Based on the investigation findings, 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 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.

• Brand Name: MI CALCAR REAMER SHAFT
• Common Device Name: HIP INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; 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: 19094001
• Report Number: 1818910-2024-08162
• Device Sequence Number: 7607318
• Product Code: HTO
• UDI-Device Identifier: 10603295143192
• UDI-Public: 10603295143192
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/11/2024
• 2 Devices were Involved in the Event: 1 2

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: 257004500
• Device Lot Number: SO2051776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2024
• Supplement Date Received by Manufacturer: 04/23/2024; 04/30/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 04/26/2024; 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown