MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SHORT HEXDRIVER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71631068

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/30/2020

Event Type  Injury  

Event Description

It was reported that during surgery of trauma nail removal, after removing a end cap using the short hexdriver, it didnt work/release.It was found the slotted end (mating part to screw driver release handle) of the device was broken off outside patient.The piece was recovered.No harm to patient.No delay.Using medium hexdriver, the surgery was continued.The device will be returned for evaluation.Please issue ra.

Manufacturer Narrative

Results of investigation: the device, used in treatment, was returned for evaluation.A visual inspection of the returned trigen short driver confirms there is a piece of the trigen short hexdriver shaft broke off.The piece was not returned.The trigen short driver and trign short hexdriver shaft were returned for evaluation.The instrument exhibits significant amount of use and wear.This device was manufactured in 2018.A medical investigation was conducted and per complaint details, the broken piece was recovered and a back-up device was used to complete the procedure.No patient injuries or adverse consequences were reported.No further clinical/medical assessment is warranted at this time.A review of complaint history on the listed parts revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal any manufacturing or material abnormalities 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.

• Brand Name: SHORT HEXDRIVER
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10442952
• MDR Text Key: 204034539
• Report Number: 1020279-2020-04158
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 03596010478436
• UDI-Public: 03596010478436
• 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: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2020
• Device Model Number: 71631068
• Device Catalogue Number: 71631068
• Device Lot Number: 18KM00438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Date Manufacturer Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention