MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 3.8MM DRILL BIT 25MM; DRILLS (BITS, SLEEVES, GUIDES) : DRILLS

Model Number 2366-84-000

Device Problems Break (1069); Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problem Not Applicable (3189)

Event Date 01/22/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the shaft part of the flex drill shaft (manufactured by alfamed, p/n: t17765, lot#: unknown) was broken when the surgeon was drilling on acetabular side during the tha surgery on (b)(6) 2020.Also, same product that was additionally shipped was used for drilling however same problem occurred.The 3.8mm drill bit 25 mm (p/n: 236684000) was attached to the flex drill shaft and inserted into the acetabular side using a drill guide, but the flex drill shaft bent at the fulcrum of the drill guide.Then same problem occurred with the 3.8mm drill bit 40 mm (p/n: 227412000).Although it was planned to implant two screws, the surgeon had to finish the surgery with only single screw which was implanted before the drill shaft broke into the acetabular cup.The surgery was completed within a 30 minutes surgical delay and there was no harm to the patient.No further information is available.

Manufacturer Narrative

 depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes heen able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary review of the returned drill bits confirms that the drill bits have been bent and cannot be used root cause undetermined depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot null device history batch null device history review null if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Added: d10.Corrected: h3.

• Brand Name: 3.8MM DRILL BIT 25MM
• Type of Device: DRILLS (BITS, SLEEVES, GUIDES) : DRILLS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9676499
• MDR Text Key: 189647696
• Report Number: 1818910-2020-04107
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 10603295120186
• UDI-Public: 10603295120186
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2366-84-000
• Device Catalogue Number: 236684000
• Device Lot Number: NG80819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Date Manufacturer Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1