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

Catalog Number 1010-01-102

Device Problems Loose or Intermittent Connection (1371); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device date of manufacture is unknown; therefore, udi: (b)(4).Reporter¿s phone number was not provided.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.

Event Description

This is report 2 of 4 for the same event.It was reported that four (4) adaptor devices were not tight and popping open when the impactor was running.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 a 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.The exact date of this event was unknown.All available has been disclosed.If additional information were to become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

Corrected data: it was reported that the device serial number was (b)(4) in the initial report.The serial number has been updated to (b)(4).The udi has been updated accordingly.The device manufacture date was documented as unknown in the initial report.It has been updated to april 27, 2017.Udi: (b)(4).The actual device was returned for evaluation.Quality engineering evaluated the device and determined that the broach adapter did not hold the actis broach securely and the locking latch unlocks when tested with the impactor.Therefore, the reported condition was confirmed.It was noted that the adapter was pre-design change which removed material from the two different surfaces to improve the latching mechanism by allowing the lever to travel further when closing.During review of the device manufacturing records for this device it was found that there were no anomalies that occurred during the manufacturing or processing of the device that would have been expected to cause or contribute to the reported event.The assignable root cause was determined to be due to device design.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: KINCISE BROACH-ADAPTER-ANTERIOR
• 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: kara ditty-bovard ; 4500 riverside drive; palm beach gardens, FL 33410 ; 6103142063
• MDR Report Key: 8200552
• MDR Text Key: 131586645
• Report Number: 1045834-2018-52522
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 00850915006013
• UDI-Public: (01)00850915006013
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/10/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 1010-01-102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 04/04/2019
• Supplement Dates FDA Received: 04/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1