MAUDE Adverse Event Report: THE ANSPACH EFFORT LLC 1.55MM X 10MM TWIST DR,S; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number S-1510TD-G1

Device Problem Material Fragmentation (1261)

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

Event Date 01/26/2022

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.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.Udi ¿ (b)(4).

Event Description

It was reported from (b)(6) that during an unknown procedure for treating a cerebral aneurysm it was observed that the tip of the drill bit device broke off while the surgeon tried to make a suture hole on the skull's bone fragment after craniotomy.The physician noted that the device was being used in its usual manner, and the rotations per minute (rpm) had changed.It was not reported if there was a delay in the procedure due to the event.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 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.A review of the device history was performed and no non-conformances were detected related to the reported condition.

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 drill bit device, and the reported condition that the tip of the drill bit broke off was confirmed.The device was visually inspected as received and it was found that the drill bit failed the visual assessment the external features of the returned drill bit device were visually inspected, and it was observed that the tip of the device was broken.The device was examined and photographed using 30x magnification.Based on the photographs taken the angle indicate that there was excessive force applied.The root cause of the customer¿s complaint that ¿drill bit broke off¿ was excessive lateral or side to side force (improper handling).The assignable root cause of this condition was determined to be traced to the user, which is user error.

• Brand Name: 1.55MM X 10MM TWIST DR,S
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): THE ANSPACH EFFORT LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: kara ditty-bovard ; 4500 riverside drive; palm beach gardens, FL 33410 ; 6107428552
• MDR Report Key: 13497471
• MDR Text Key: 285819795
• Report Number: 1045834-2022-00147
• Device Sequence Number: 1
• Product Code: HBB
• UDI-Device Identifier: 00845384012610
• UDI-Public: 00845384012610
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K113476
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S-1510TD-G1
• Device Catalogue Number: S-1510TD-G1
• Device Lot Number: R153145961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1