MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LARGE SCREWDRIVER HANDLE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71173547
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/31/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after the procedure, the driver handle was attached to the driver shaft.The procedure was complete without delay and with the same device.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Updated b5: description of problem.
Event or Problem Description
It was reported that after the procedure, the driver handle was attached to the driver shaft.The procedure that was performed before finding the problem with the device, was completed without delay and with the same device.The backup was not necessary.No patient injury or other complications were reported.
Additional Manufacturer Narrative
H6: the device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirmed the stated failure mode.The device is lodged together and cannot be removed, rendering the device inoperable.The device shows signs of extensive use.A review of complaint history did not reveal additional complaints.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.Damage from prolonged use, misuse or rough handling are likely probable causes 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: LARGE SCREWDRIVER HANDLE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10446366
• Report Number: 1020279-2020-04169
• Device Sequence Number: 3974915
• Product Code: HSB
• UDI-Device Identifier: 03596010519580
• UDI-Public: 03596010519580
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/28/2021

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: 71173547
• Device Catalogue Number: 71173547
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Initial Date Received by Manufacturer: 07/31/2020
• Supplement Date Received by Manufacturer: 07/31/2020; 07/28/2021
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 09/07/2020; 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1