MAUDE Adverse Event Report: SMITH & NEPHEW, INC. QUICK CLAMP 10.5MM TO 5MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	71067372
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, when surgeon tried to tighten the clamp, the clamp screw sheared off.No injury reported and all pieces were retrieved from patient, there was no delay and a backup device from smith and nephew was used to complete the procedure.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The threads on the compression bolt fractured off the device, causing it to disassemble.All pieces were returned except for one of the springs.The device was manufactured in 2018 and exhibits significant signs of use.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The potential probable cause for this event could include over stressing/ torqueing.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: QUICK CLAMP 10.5MM TO 5MM
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8884272
• Report Number: 1020279-2019-03019
• Device Sequence Number: 2549036
• Product Code: KTT
• UDI-Device Identifier: 03596010607867
• UDI-Public: 03596010607867
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K072212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71067372
• Device Catalogue Number: 71067372
• Device Lot Number: 18LSM0632
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 08/12/2019
• Supplement Report FDA Received Date: 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1