MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GUIDE BOLT WRENCH; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71631140
Medical Device Problem Codes	Break (1069); Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/03/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery the intertan nail was implanted and the procedure went perfectly.After the lag and compression screws were inserted the set screw was advanced.When the guide bolt wrench was applied to remove the nail from the drill guide the guide bolt wouldn't come out.Additional force was applied to the driver and it broke inside the patient, all pieces recovered.The implant was removed because it could not be release from the drill guide because the hex driver broke.The surgeon had to use a competitor's device.The patient was discharged from the hospital.A delay greater than 30 min was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device, used in treatment was returned for evaluation.Visual inspection of the returned device confirms that the device is broken, damaged and has signs of wear and tear from use.The device was manufactured in 2015.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 complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.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: GUIDE BOLT WRENCH
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10317527
• Report Number: 1020279-2020-03463
• Device Sequence Number: 14027811
• Product Code: HSB
• UDI-Device Identifier: 03596010419644
• UDI-Public: 03596010419644
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 10/29/2020

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: 71631140
• Device Catalogue Number: 71631140
• Device Lot Number: 08HM14793
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/03/2020
• Supplement Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCREWDRIVER PART NUMBER UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention