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

Model Number 71674070

Device Problem Material Fragmentation (1261)

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

Event Date 11/12/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, during an unknown procedure, the tip of the drill of a 7.0 compression screw drill broke off inside the nail.The instruments were inside the patient.The procedure was completed with the compression drill, the broken piece was retrieved with pituitary forceps.The device is not available.There was no significant delay or further complications reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H6: the device, used in treatment, was not returned for evaluation but the pictures were reviewed, and the failure mode was confirmed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Damage from misuse or rough handling are likely probable causes of the reported event.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: 7.0 COMPRESSION SCREW DRILL
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10955767
• MDR Text Key: 219862893
• Report Number: 1020279-2020-07003
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 03596010560636
• UDI-Public: 03596010560636
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2021
• Device Model Number: 71674070
• Device Catalogue Number: 71674070
• Device Lot Number: 11CHU0013
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention