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

Model Number 1013-00-901

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/02/2022

Event Type  malfunction  

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.Additional narrative: analysis of a photo of the device found that the device was cracked and broken in 2+ pieces.Therefore, the reported condition was confirmed.The damage is consistent with the device having been dropped or mis- aligned during use.Device history record shows that this lot of product was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacturing process.The assignable root cause was determined to be due to user error.Udi: (b)(4).

Event Description

It was reported that the impactor device head impactor tip was cracked.During an in-house engineering evaluation, it was determined that a photo of the device confirmed that the device was cracked and also broken in 2+pieces.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in the surgical procedure, or if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: KINCISE¿ FEM HEAD IMPACTOR, REPLACE CAP
• Type of Device: 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: 15716291
• MDR Text Key: 302942288
• Report Number: 1045834-2022-01464
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 00845384018629
• UDI-Public: 00845384018629
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1013-00-901
• Device Catalogue Number: 1013-00-901
• Device Lot Number: JJAN00036
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1