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

Catalog Number 1010-01-102

Device Problems Device-Device Incompatibility (2919); Difficult or Delayed Separation (4044)

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

Event Date 05/09/2023

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.The initial reporter's facility address 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.Udi: (b)(4).

Event Description

It was reported that during pre-surgery, it was discovered that the anterior broach adapter device kept getting stuck on the attachment device so the surgeon could not switch the broach for a bigger size.It was reported that broach device could be removed from the attachment device.It was not reported if there were any delays in the surgical procedure or if a spare device was available for use.There was no 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

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: b5: upon subsequent follow-up with the customer, additional information was received stating the device was broken device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed by quality engineering, and it was determined that the device failed visual inspection because of the guide pin damage.It was further determined that the guide pin damage caused the broach not to attach which was consistent with the broach not being properly secured.It was further determined that the device failed pretest for visual assessment, locking latch attachment assessment and locking latch removal assessment.Therefore, the reported condition was confirmed.The assignable root cause was determined to be traced to user, which is user error due to improper handling.

• 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 Contact: kate karberg ; 4500 riverside drive; palm beach gardens, FL ; 3035526892
• MDR Report Key: 16930503
• MDR Text Key: 315218352
• Report Number: 1045834-2023-00740
• Device Sequence Number: 1
• Product Code: GEY
• 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
• Report Date: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1