MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 1.8MM DRILL SHORT W/AO QC; BIT, DRILL

Model Number 71174905

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 03/17/2021

Event Type  malfunction  

Event Description

It was reported that when a sterile 1.8mm drill short w/ao qc was opened from the inside packaging had been pierced by the drill bit, consequently making it unsterile.It was noticed that the protective ends had come loose from the drill in transit.The procedure was successfully completed without significant delay using a back-up device.No patient injury or other complications were reported.

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation.The photo attached to the complaint cannot confirm the stated failure.The product support manager for this product line was made aware of the complaint.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Some potential probable causes for this event could include packaging damage in transit or storage.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: 1.8MM DRILL SHORT W/AO QC
• Type of Device: BIT, DRILL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11646833
• MDR Text Key: 244843739
• Report Number: 1020279-2021-02836
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 00885556386545
• UDI-Public: 00885556386545
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71174905
• Device Catalogue Number: 71174905
• Device Lot Number: 19GUQ0014
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1