MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RATCHET WRENCH; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	71070367
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the wrench was sticking and not working properly during the external fixation case.The procedure was completed using an smith&nephew backup device.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection of the device did not confirm any noticeable damage that could cause the device to fail.This device was manufactured in 2014.This device shows signs of significant wear/usage.A functional evaluation was conducted and the failure mode is confirmed as the returned device would not "ratchet" correctly on the tighten end of the wrench.Upon further functional inspection, the set screw was discovered to be set too far into the handle as called out on the drawing print.It could not be determined how the set screw was placed in this position, resulting in the detent ball to bind into the socket and not allowing it to ratchet correctly.Upon returning the set screw to its correct position per the drawing print, it is now functioning correctly and as intended.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.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: RATCHET WRENCH
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10503222
• Report Number: 1020279-2020-04461
• Device Sequence Number: 3222633
• Product Code: KTT
• UDI-Device Identifier: 00885556119174
• UDI-Public: 00885556119174
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K093047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2020

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: 71070367
• Device Catalogue Number: 71070367
• Device Lot Number: 14APM0010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1