MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 2.0NM TORQUE LIMITER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	71173622
Medical Device Problem Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during surgery, the device didn't work when fastening the last screw out of 7 screws.The other 6 screws fastened with the device before the event happen.The procedure finished without the device; the last screw was fasted without the device (change in surgical technique).No injury was reported and there was a 3 min delay.
Additional Manufacturer Narrative
The device, used in treatment was returned for evaluation.Visual inspection of the returned device confirms that the device has signs of wear and tear from use.Functional testing of the returned device confirms that the torque limiter doesn't fasten the screw.The device was manufactured in 2013.According to clinical/medical investigation, this case reports the torque limiter did not fasten the last of 7 screws.Per email communication, the last screw was fastened without use of the device.There was no patient injury, and the procedure was completed with a minimal delay.No further clinical assessment is warranted.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 complaint history for the listed part revealed no prior complaints at this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further actions are being taken at this time.We consider this investigation closed.Credit will be issued for the device.

• Brand Name: 2.0NM TORQUE LIMITER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10339663
• Report Number: 1020279-2020-03568
• Device Sequence Number: 3032279
• Product Code: LXH
• UDI-Device Identifier: 03596010637239
• UDI-Public: 03596010637239
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71173622
• Device Catalogue Number: 71173622
• Device Lot Number: 13LPM0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 03/14/2021
• 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: Required Intervention