MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC KINCISE¿ PINNACLE® SHELL/LINER IMPACTOR; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number	1011-01-101
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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, 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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11 additional narrative: the actual device has been returned and is currently pending evaluation.Once the evaluation has been completed, a supplemental medwatch report will be sent accordingly.
Event or Problem Description
It was reported that during pre-surgery, it was observed that the t-handle cup impactor is stripped into and locked into the impactor.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.
Additional Manufacturer Narrative
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, 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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The actual was returned for evaluation.The device was visually inspected as received from the customer.It was found that the device failed visual inspection due to corrosion.Investigation is based on the assessment performed by the complaint technical investigator.The device failed the following inspection criteria¿s during the functional assessment: 2.4.1 visual assessment: fail 2.5.2 cloverleaf fitting assessment: fail 2.5.3 cloverleaf fitting assessment: fail 2.6.1 adaptor removal assessment: fail the kincise cup-adapter was visually and functionally assessed and determined to fail the cloverleaf fitting assessment because it is stuck to the kincise impactor.The adapter was forcibly removed, and the cloverleaf end was noticeably damaged.Also, the impactor locking collar is damaged due to the stuck adapter not properly secured ¿ user error (reference pc-(b)(4) for the impactor investigation information).No further action is required at this time since the issues are consistent with user error.Root cause comments: the most relevant root cause is linked to improper handling - user error.

• Brand Name: KINCISE¿ PINNACLE® SHELL/LINER IMPACTOR
• Common Device Name: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: kate karberg ; 4500 riverside drive; palm beach gardens, FL 33410 ; 3035526892
• MDR Report Key: 21284945
• Report Number: 1045834-2025-00073
• Device Sequence Number: 18119912
• Product Code: GEY
• UDI-Device Identifier: 00845384018575
• UDI-Public: (01)00845384018575
• Combination Product (Y/N): N
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2025

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: 1011-01-101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown