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 Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/11/2018

Event Type  Injury  

Event Description

The tip of the drill bit has snapped inside the patient and has been unable to be retrieved.Surgery was delayed for over 30 minutes and the broken bit was left inside as the patient could not withstand the pain as the procedure was one under spinal.

Manufacturer Narrative

The affected device was returned and evaluated.A visual inspection of the 7mm starter drill confirmed the complaint that the tip of the drill has snapped off.The severed piece was not shipped with instrument.We recommend that all reusable instruments be routinely inspected for wear and damage so they can be replaced as necessary.The complaint history revealed no additional complaints for the associated batch.Additionally, a review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Insufficient clinically relevant documentation was provided to perform a thorough medical assessment on the root cause of the instrument breakage; however, overload fractures can occur if the mechanical loads applied to the re-use compression screw drill exceed the strength of the material.The 17-4 ph ss alloy is not approved/intended for implantation.The patient impact beyond the 30+ minutes delay and pain during the attempted extraction procedure itself cannot be determined, as the non-implantable foreign body/drill tip of unknown size reportedly remains within the patient in an unknown location.Although it was communicated that the surgeon did not anticipate any further patient impact, the patient's current status remains unknown, as well as if micro-motion is likely to occur.Based on this investigation, the need for corrective action is not indicated.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.Credit has been issued for this device.

• 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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 101 hessle road; hull hu3 2bn; UK
• MDR Report Key: 7653904
• MDR Text Key: 112838385
• Report Number: 1020279-2018-01250
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00885556389393
• UDI-Public: 00885556389393
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K122170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 71674570
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/11/2018
• Initial Date FDA Received: 06/30/2018
• Supplement Dates Manufacturer Received: 06/11/2018
• Supplement Dates FDA Received: 10/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention