MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 7.0MM COMP SCREW STARTER DRILL; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 71674570

Device Problem Break (1069)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 10/12/2018

Event Type  malfunction  

Event Description

It was reported that a malfunction occurred during surgery.Drill was inserted down the drill guide.When the drill was activated the tip of the drill snapped off in patient.The surgeon was able to remove the broken piece and no further complications arose as a result of this.

Manufacturer Narrative

The affected intertan 7.00 compression starter drill was not returned for evaluation.A relationship, if any, between the subject affected device and the reported event could not be determined since the product was not returned for evaluation.Although the complainant indicated, the device was to be returned it has not been received by the manufacturer.As the device was not made available for investigation, the failure mode cannot be determined or confirmed.Additionally, the batch number was not provided; thus, a review of the manufacturing records cannot be conducted.Without the return of the actual product involved and no batch information available, our investigation of this report is inconclusive.Several potential factors that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to/after each use and cleaning.Additionally, failure to adhere to the warnings and precautions outlined in the instructions for use could result in damage and or impact the device functionality.There are no indications to suggest the device did not meet product specifications upon release into distribution.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: INTERTAN 7.0MM COMP SCREW STARTER DRILL
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8105582
• MDR Text Key: 128398246
• Report Number: 1020279-2018-02382
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K122170
• 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: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71674570
• Device Lot Number: UNKNOWN
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1