MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US BROACH CORAIL AMT 12; HIP INSTRUMENTS : BROACHES

Catalog Number	L20412
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
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.H11 additional manufacturer narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
It was reported that the broach has worn away near where neck trial sits so it is loose when neck trial sits on broach.There was no surgical delay.There were no patient consequences.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: according to the information received, "broach has worn away near where neck trial sits so it is loose when neck trial sits on broach." the product was not returned to medtech orthopaedics; however, photos were provided for review.See attachment "img_(b)(4).Jpeg".The photo investigation of "l20412, broach corail amt 12" can not revealed the reported condition, as, the evidence provided was not sufficient to confirm the reported event of unable to assemble.Functionality issues cannot be evaluated through photo investigation.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the observed condition of the broach corail amt 12 would not contribute 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 complaint condition.As part of 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 device lot number is unknown; therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.
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: d4 (lot), d9, h4.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: broach has worn away near where neck trial sits so it is loose when neck trial sits on broach.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis found that the broach corail amt 12 was returned disengaged, nothing indicative of a device nonconformance was identified.The sample only exhibits signs of repetitive use for a long period of time.Even though a proper assessment was not performed due to the mating component was not returned.For reference a functional evaluation was conducted using a lab sample mating device and the broach does not shows difficulties while assembling or disassembling, no loosening was noted.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 broach corail amt 12 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: a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the date code a0208 provided is not a valid finished goods lot number.Corrected: h3.

• Brand Name: BROACH CORAIL AMT 12
• Common Device Name: HIP INSTRUMENTS : BROACHES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22161566
• Report Number: 1818910-2025-09272
• Device Sequence Number: 7422057
• Product Code: HTQ
• UDI-Device Identifier: 10603295258148
• UDI-Public: (01)10603295258148(10)A0208
• 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,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: L20412
• Device Lot Number: A0208
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: 06/16/2025; 08/19/2025; 09/03/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 06/17/2025; 08/21/2025; 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2008
• 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