MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC KINCISE¿ FEM HEAD IMPACTOR, REPLACE CAP; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Model Number	1013-00-901
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unspecified surgical procedure, it was discovered that the surgeon was using the femoral head impactor device to impact the final femoral head.The device broke into two pieces on the last impaction.It was reported that all of the pieces were retrieved from the patient.It was reported that there were no delays in the surgical procedure.It was not reported if a spare device was available for use.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Additional narrative: the serial number was unknown; therefore, the device manufacture date is unknown, and the udi is incomplete.The surgeon¿s phone number was not provided.However, the reporter¿s name, phone number and email address were provided as (b)(6).The actual device has been returned and is currently pending evaluation.Once the investigation has been completed, and if additional information should become available, a supplemental medwatch report will be submitted accordingly.Udi: serial number unknown (b)(4).
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 this medwatch, a supplemental medwatch report will be filed as appropriate.H10 additional narrative: device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed, and it was determined that the kincise replacement cap was cracked, which was probably due to it being dropped or misaligned during use.It was further determined that the device failed pretest for visual assessment and end cap thread assessment.It was determined that the failure was consistent with user error.Therefore, the reported condition was confirmed.The assignable root cause was determined to be traced to user, which is user error.

• Brand Name: KINCISE¿ FEM HEAD IMPACTOR, REPLACE CAP
• Common Device Name: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): TECHTRONIC INDUSTRIES MEDICAL; 1428 pearman dairy rd; anderson SC 29625
• Manufacturer Contact: kate karberg ; 4500 riverside drive; palm beach gardens, FL 33410 ; 3035526892
• MDR Report Key: 14346240
• Report Number: 1045834-2022-00557
• Device Sequence Number: 14757435
• Product Code: GEY
• UDI-Device Identifier: 00845384018629
• UDI-Public: 00845384018629
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2022

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 Model Number: 1013-00-901
• Device Catalogue Number: 1013-00-901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2022
• Supplement Date Received by Manufacturer: 07/01/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 75 YR
• Patient Sex: Female