MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 BASEPLATE INSERTER HANDLE; SHOULDER INSTRUMENT - INSERTION DEVICE

Catalog Number	650011101
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the inhance baseplate inserter rod cross-threaded into a definitive baseplate implant, and could not be separated.The implant wasted, and inserter rod useless.There was a surgical delay of five (5) minutes.New instrument set and new small baseplate were opened.The procedure was completed successfully.There were no patient consequences.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Depuy orthopaedics is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy orthopaedics has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy orthopaedics or its employees that the report constitutes an admission that the device, depuy orthopaedics, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.H11 additional narrative: added: d4 (lot), d9, g1 (manufacturing site name), h4.Corrected: d4 (primary udi number).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 according to the information received "inhance baseplate inserter rod cross-threaded into a definitive baseplate implant, couldn't separate them.Implant wasted; inserter rod useless".The product was not returned to depuy synthes; however, photos were provided for review.See attachment ¿img_2258.Jpeg'.The evidence provided was not sufficient to confirm the reported event jammed/seized.Functionality issues and device interaction issues cannot be evaluated through a photo investigation.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the photographs attached don¿t have any evidence to draw a conclusion about the reported event.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 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 in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary inhance baseplate inserter rod crossthreaded into a definitive baseplate implant, couldn't separate them.Implant wasted, inserter rod useless.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the baseplate inserter handle remained attached to the baseplate inserter rod and modular uniti baseplate s 24, additionally the baseplate inserter handle was unable to disengage after multiples attempts, the reported jammed condition was confirmed.The functional tests revealed that after an excessive amount of force was applied, the devices could not be disassembled, confirming the reported complaint condition.The observed condition of the device may be consistent with a component failure resulting from exposure to unintended forces, such as overtightening during assembly or the assembly of the devices in a misaligned position.However, based on the available information and the fact that the threads of the involved devices could not be examined due to their jammed condition, the potential cause cannot be established the overall complaint was confirmed as the observed condition of the baseplate inserter handle 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.

• Brand Name: BASEPLATE INSERTER HANDLE
• Common Device Name: SHOULDER INSTRUMENT - INSERTION DEVICE
• 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 ; 3035526892
• MDR Report Key: 21503588
• Report Number: 1818910-2025-03274
• Device Sequence Number: 14553073
• Product Code: LXH
• UDI-Device Identifier: 10603295547228
• UDI-Public: (01)10603295547228(10)217562
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: 650011101
• Device Lot Number: 217562
• 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: 02/12/2025
• Supplement Date Received by Manufacturer: 03/11/2025; 03/13/2025; 04/10/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 03/12/2025; 03/14/2025; 04/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2000
• 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