MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC KINCISE BULLET TIP STEM INSERTER; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 1012-01-101

Device Problem Material Fragmentation (1261)

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

Event Date 11/11/2020

Event Type  malfunction  

Manufacturer Narrative

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 serial number was unknown, therefore, the device manufacture date is unknown.The surgeons phone number was not provided.However, the reporters name and phone number were provided as (b)(6).As of this date, the device has not been returned for evaluation, therefore, the reported condition cannot be confirmed, and/or duplicated.Udi: serial number unknown; (b)(4).

Event Description

It was reported that during an unspecified surgical procedure, it was discovered that while the surgeon was using the bullet tip stem inserter device, the white head of the device snapped in two.It was reported that all the pieces were retrieved from the patient.It was not reported if there were any delays in the surgical procedure or 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.Reference manufacturer report number: this report was initially submitted under 1818910-2020-25453.

• Brand Name: KINCISE BULLET TIP STEM INSERTER
• 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: kara ditty-bovard ; 4500 riverside drive; palm beach gardens, FL 33410 ; 6103142063
• MDR Report Key: 10991725
• MDR Text Key: 220961451
• Report Number: 1045834-2020-02104
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012-01-101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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