MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JETX 4.8 SHT GRAD STEP DRILL; BIT, DRILL

Catalog Number 71063026

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/26/2019

Event Type  malfunction  

Event Description

It was reported that, during drilling, it was found the tip of the drill had been bent under x-ray image.Backup device was available and the surgery delayed 1 hour.

Manufacturer Narrative

The associated devices were returned and evaluated.A visual inspection of the returned devices confirmed the stated failure modes.The drill is bent, rendering it inoperable.It also has numerous score marks from excessive use.The tube on the drill sleeve is loose, rendering it inoperable.The devices were manufactured in 2005 and 2016 and exhibit signs of extensive wear/usage.A review of complaint history for the drill did not reveal additional complaints for the listed batch.A review of the manufacturing records for the drill did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: JETX 4.8 SHT GRAD STEP DRILL
• Type of Device: BIT, DRILL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8914950
• MDR Text Key: 155022880
• Report Number: 1020279-2019-03098
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 00885556013458
• UDI-Public: 00885556013458
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71063026
• Date Manufacturer Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1