MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 7/16 GUIDE BOLT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71674071
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during surgery, the tip 7/16 guide bolt cross-threaded into the nail resulting in not being able to release the nail from the intertan drill guide.Surgery was completed by using a competitor device.Surgery was not significantly delayed.Patient was not harmed.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms no relevant clinical information was provided for inclusion in this investigation.Based on the information provided, the reported connection issue occurred during use outside of the patient.Per report, a competitor¿s device was used to complete the procedure without a significant delay.Since it was reported there was no harm to the patient, no further clinical/medical assessment is warranted at this time.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 risk management file revealed this failure mode was previously identified.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.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.
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 device is lodged together with its mating component and cannot be removed, rendering the device inoperable.The clinical/medical evaluation concluded that no relevant clinical information was provided for inclusion in this investigation.Based on the information provided, the reported connection issue occurred during use outside of the patient.Per report, a competitor¿s device was used to complete the procedure without a significant delay.Since it was reported there was no harm to the patient, no further clinical/medical assessment is warranted at this time.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 do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Potential probable causes could include but are not limited to assembly issue, procedural/user error, and unclear user instructions.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: 7/16 GUIDE BOLT
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11699934
• Report Number: 1020279-2021-03268
• Device Sequence Number: 3481332
• Product Code: HSB
• UDI-Device Identifier: 03596010560643
• UDI-Public: 03596010560643
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/19/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71674071
• Device Catalogue Number: 71674071
• Device Lot Number: 20GT39859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Initial Date Received by Manufacturer: 03/27/2021
• Supplement Date Received by Manufacturer: 05/20/2021; 08/17/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 05/21/2021; 08/19/2021
• 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: Hospitalization; Other; Required Intervention