MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC KINCISE CUP-ADAPTER-PINNACLE STRAIGHT; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 1011-01-101

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device manufacture date: the device manufacture date is unavailable.Concomitant med products and therapy dates: attachment devices, impactor device, (b)(6) 2019.The 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 submitted accordingly.

Event Description

It was reported that during an unspecified surgical procedure, it was discovered that while attaching the kincise cup-adapter-pinnacle device, it would not lock onto the impactor device.It was reported that all other attachment devices worked well.It was further reported that it looked like there was a little wear at the attachment points for the cup/liner instrument that was keeping the device from fully locking into place.It was reported that there was no loosening and the loosening interface was non-cemented.There were no delays to 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.

Manufacturer Narrative

Device manufacture date: the device manufacture date was unknown in the initial report.The device manufacture date has been updated as 6/18/2018.Device history review: the actual device was not returned for evaluation; therefore, the reported condition was not confirmed.However, a device history review was performed which indicated that there were no non-conformances or abnormalities identified during the manufacture of the device that may have contributed to the reported condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: KINCISE CUP-ADAPTER-PINNACLE STRAIGHT
• 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: 8616377
• MDR Text Key: 145264215
• Report Number: 1045834-2019-53618
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 00850915006099
• UDI-Public: 850915006099
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1011-01-101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2018
• 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
• Patient Age: 32 YR