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

Model Number	71674071
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during an internal fixation surgery, the distal screw holes did not align properly.It is unknown if the 7/16 guide bolt, 125 rad drill gde drop, 130 rad drill gde drop or drill guide handle caused the misalignment.Procedure was completed with a back-up device without any delay.Patient was not harmed.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection of the returned device does not confirm the stated failure mode.The device shows signs of extensive use.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.Please see results from case-2020-00065980-1.All parts passed their respective ip/id inspections.A dimensional evaluation determined that all returned parts are 8-13 years old.We currently have no way to test the targeting assembly with respect to what is performed in the field.All parts mate correctly.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.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.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: 12307696
• Report Number: 1020279-2021-06297
• Device Sequence Number: 3671302
• Product Code: HSB
• UDI-Device Identifier: 03596010560643
• UDI-Public: 03596010560643
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2021

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: 71674071
• Device Catalogue Number: 71674071
• Device Lot Number: 17KM02634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 08/11/2021
• Supplement Report FDA Received Date: 10/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1