MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC KINCISE¿ ANTERIOR BROACH ADAPTER; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Model Number 1010-01-102

Device Problems Device-Device Incompatibility (2919); Mechanical Jam (2983)

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

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.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: the reporter¿s phone number was not provided.Concomitant med products and therapy dates: broach adapter devices 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).

Event Description

This is report 2 of 3 of the same event: it was reported from united kingdom that during a device demonstration, it was observed that the broach adapter devices were stiff, and another instrument had to be used to separate the broaches from the adapters once they were locked in.The event was not related to surgery.There was no patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: KINCISE¿ ANTERIOR BROACH ADAPTER
• 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: 15879623
• MDR Text Key: 305702640
• Report Number: 1045834-2022-01607
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 00845384018568
• UDI-Public: 00845384018568
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1010-01-102
• Device Catalogue Number: 1010-01-102
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1