MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 KINCISE 1 EMPHSYS STRGHT IMPCT; POWER TOOL ADAPTOR

Catalog Number	200015005
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the kincise emphasys adapter would not screw into the cup.The issue was observed during surgery.There were no reports of injuries, medical intervention or prolonged hospitalization.It was reported that there was no further information regarding the issue.All available information has been disclosed.
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).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: d9.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: it was reported that the item the kincise emphasys adapter that would not screw into the cup.The issue was observed during surgery.There were no reports of injuries, medical intervention or prolonged hospitalization.It was reported that there was no further information regarding the issue.All available information has been disclosed.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device revealed that the tip of the kincise 1 emphsys strght impct was deformed.No other damage was found.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended and excessive forces, such as repeated impaction forces while the device is not fully threaded or in a misaligned position.A functional test was not performed as the mating device was not returned for evaluation.However, based on the observed damage to the tip, it is reasonable to conclude assembly issues can be presented.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the kincise 1 emphsys strght impct would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to unintended use 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 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.H11 additional narrative: corrected: h3.

• Brand Name: KINCISE 1 EMPHSYS STRGHT IMPCT
• Common Device Name: POWER TOOL ADAPTOR
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22373892
• Report Number: 1818910-2025-11035
• Device Sequence Number: 8091552
• Product Code: HWE
• UDI-Device Identifier: 10603295527848
• UDI-Public: (01)10603295527848(10)GM6127718
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,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: 200015005
• Device Lot Number: GM6127718
• 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: 06/12/2025
• Supplement Date Received by Manufacturer: 07/03/2025; 07/11/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 07/04/2025; 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2023
• 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