MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUBTROC LAG SCREW HEXDRVR ROD; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71674086
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The tip of the threaded section of the device fractured off and was not returned.The device was manufactured in 2016 and exhibits signs of extensive wear / usage.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 have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.We recommend that all reusable instruments be routinely inspected for wear and 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 investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Credit will be issued for the device.
Event or Problem Description
It was reported that during surgery the tip off the retention rod broke while compressing the lag screw.No delay nor injury was reported.A back up was available but not required to finish the surgery.No fragments fell inside the patient.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The tip of the threaded section of the device fractured off and was not returned.The device was manufactured in 2016 and exhibits signs of extensive wear usage.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 have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.We recommend that all reusable instruments be routinely inspected for wear and 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 investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: SUBTROC LAG SCREW HEXDRVR ROD
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9282332
• Report Number: 1020279-2019-03904
• Device Sequence Number: 16827893
• Product Code: HSB
• UDI-Device Identifier: 03596010580290
• UDI-Public: 03596010580290
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2019

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 Catalogue Number: 71674086
• Device Lot Number: 16JSP0012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 11/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1