MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC KINCISE¿ PINNACLE® SHELL/LINER IMPACTOR; IMPACTOR, ADAPTERS, BATTERY, BATTERY CHARGER

Model Number 1011-01-101

Device Problems Device Markings/Labelling Problem (2911); Device-Device Incompatibility (2919)

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

Event Date 12/07/2022

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.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: concomitant med products and therapy dates: multihole ii cup 54mm (b)(6) 2022).Udi: lot/serial unknown.(b)(4).Device manufacture date: the device manufacture date is unavailable as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.

Event Description

It was reported that during an unspecified surgical procedure it was observed that the impactor device cold welded to the cup device.It was reported that there was no delay in the procedure due to the event.It was reported that a new spare cup device was opened to continue the procedure.There was patient involvement reported.It was reported that all pieces were retrieved.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 will be submitted accordingly.

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 actual device has been returned and is currently pending evaluation.Once the evaluation of the device has been completed, a supplemental medwatch report will be sent accordingly.Udi - (b)(4) h10 correction: d4, h4: the device serial number was documented as unknown in the initial medwatch report.The serial number (b)(6) has been updated accordingly.The date of manufacture (dom) was documented as unknown in the initial medwatch report.The dom has been corrected to september 5, 2019.The udi has been updated accordingly.

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 actual device was returned for evaluation.Quality engineering evaluated the impactor device and observed that the device failed visual inspection.The cup-adapter was visually and functionally assessed and determined to have thread damage consistent with user error.It was further determined that the device failed pretest for visual assessment, and thread fitting assessment.The assignable root cause of these conditions was determined to be due to improper handling, which is user error.Correction: d9: correction: d9: the date returned to manufacturer was inadvertently documented as december 22, 2022 on the initial report.This date has been updated to december 21, 2022.

• Brand Name: KINCISE¿ PINNACLE® SHELL/LINER IMPACTOR
• Type of Device: IMPACTOR, ADAPTERS, BATTERY, BATTERY CHARGER
• 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: 15986760
• MDR Text Key: 306700417
• Report Number: 1045834-2022-01720
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 00845384018575
• UDI-Public: 00845384018575
• 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,Followup,Followup

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 Model Number: 1011-01-101
• Device Catalogue Number: 1011-01-101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 12/22/2022; 02/03/2023
• Supplement Dates FDA Received: 12/29/2022; 02/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2019
• 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 Sex: Male