MAUDE Adverse Event Report: SYNTHES GMBH 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	06/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unspecified surgical procedure, it was discovered that the femoral head impactor device broke into two pieces.It was reported that as the surgeon was impacting the head onto the stem with the impactor, the white head impactor cracked in half upon impaction.All pieces were retrieved from the patient.It was reported that the broken tip was discarded.It was not reported if there were any delays in the surgical procedure or 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 surgeon¿s phone number was not provided.However, the reporter¿s name, phone number and email address were provided as (b)(6).The serial number was unknown; therefore, the device manufacture date is unknown, and the udi is incomplete.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi: (b)(4).

• Brand Name: KINCISE¿ FEM HEAD IMPACTOR, REPLACE CAP
• Common Device Name: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): SYNTHES GMBH; 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: 14829298
• Report Number: 1045834-2022-00753
• Device Sequence Number: 14660936
• Product Code: GEY
• UDI-Device Identifier: 00845384018629
• UDI-Public: 00845384018629
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/27/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Female