MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.0MM DRILL SLEEVE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71674083
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery while the instrument was outside the patient, the intertan distal screw targeting setup failed causing surgeon to drill into nail., surgeon free handedly reset the drill and the procedure was completed with the same nail, and it does not affect the surgical technique.Delay reported of less or equal than 30 minutes.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirmed the stated failure mode.The device was bent and has multiple damaged areas that prevented proper function.The device was manufactured in 2008 and exhibits signs of significant wear/usage.A medical investigation was conducted and this complaint from the united states reports the targeting setup failed causing surgeon to drill into nail.Reportedly, the surgeon free handedly reset the drill and the procedure was completed with the same nail, and it does not affect the surgical technique.A delay was reported of less than or equal to 30 minutes.To other complication was reported.No harm or impact to the patient.Smith and nephew has not received adequate materials (operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.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.A review of risk management files found that the reported failure was documented appropriately.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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.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: 4.0MM DRILL SLEEVE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10618445
• Report Number: 1020279-2020-05075
• Device Sequence Number: 16795297
• Product Code: HSB
• UDI-Device Identifier: 03596010560803
• UDI-Public: 03596010560803
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2020

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
• Operator of Device: Health Professional
• Device Model Number: 71674083
• Device Catalogue Number: 71674083
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 09/05/2020
• Supplement Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 10/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention