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

Catalog Number	257004500
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the head came loose from the shaft during surgery (potential for the calcar reamer to have been on reverse) and surgeon noted that it looked like something dark (potentially metal or something not normal) was on the shaft of the corail broach.Removed the items and used the mill to complete instead in the set.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : issue: the head came loose from the shaft during surgery (potential for the calcar reamer to have been on reverse) and surgeon noted that it looked like something dark (potentially metal or something not normal) was on the shaft of the corail broach.Surgeon noted that they didn't feel like it was doing anything when on there.Removed the items and used the mill to complete instead in the set.The two pieces were tagged, placed to side in bag.Discussed having the components not replaced in the tray - will collect when decontaminated for inspection.Discussed with ot about talking to the cssd team about cleaning practices and inspection of the gear.The product was not returned to j&j medtech orthopaedics, however photos were provided for review.The photo investigation revealed found normal signs of usage on the device after a surgery procedure.However signs of a black unknown substance can be seen on the calcar reamer shaft confirming the reported foreign substance/debris/cleaning/sterilization allegation.It is suspected that this condition could be consistent with multiple uses under extreme eccentric loading that may cause the friction and originated this condition.However, without concrete evidence or further information, it is not possible to determine a root cause.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the mi calcar reamer shaft would have contributed to the complained device issue.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 reported complaint condition.As part of j&j medtech orthopaedics 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.
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 that 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.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint(b)(4).Investigation summary : issue: the head came loose from the shaft during surgery (potential for the calcar reamer to have been on reverse) and surgeon noted that it looked like something dark (potentially metal or something not normal) was on the shaft of the corail broach.Surgeon noted that they didn't feel like it was doing anything when on there.Removed the items and used the mill to complete instead in the set.The two pieces were tagged, placed to side in bag.Discussed having the components not replaced in the tray - will collect when decontaminated for inspection.Discussed with ot about talking to the cssd team about cleaning practices and inspection of the gear.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device did not found signs of foreign substance.Additionally signs of worn can be found according to the time of service of the mi calcar reamer shaft no other indicative of a device nonconformance was found.A functional test was performed with the the alleged calcar planer and the reamer shaft didn't show difficulties for assembling and staying well fitted.The reported unable to assembled condition was not able to be replicated.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was not confirmed as the observed condition of the mi calcar reamer shaft would have not contributed to the complained device issue.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 reported complaint condition.As part of j&j medtech orthopaedics 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: 20299849
• Report Number: 1818910-2024-20105
• Device Sequence Number: 21004227
• Product Code: HTO
• UDI-Device Identifier: 10603295143192
• UDI-Public: (01)10603295143192(10)SO2037278
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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,Followup
• Report Date (Section B): 09/25/2024

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: 257004500
• Device Lot Number: SO2037278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: 12/05/2024; 12/09/2024; 01/16/2025
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 12/06/2024; 12/11/2024; 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2018
• 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