MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANNULATED IMPACTOR- MED; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71675081
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, devide broke due to normal wear and tear.Malfunctioned within the patient, all pieces were removed.No delay and no injury reported.Backup device available.
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 threaded end of the device fractured off and was not returned.The device was manufactured in 2012 and shows 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 do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.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.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.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation, the reported event could not be confirmed.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 products failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed part revealed prior complaints for the listed batch/failure mode.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.Based on this investigation, the need for corrective action is not indicated.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.

• Brand Name: CANNULATED IMPACTOR- MED
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9612488
• Report Number: 1020279-2020-00356
• Device Sequence Number: 16804849
• Product Code: HSB
• UDI-Device Identifier: 03596010648600
• UDI-Public: 03596010648600
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/16/2020

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: 71675081
• Device Catalogue Number: 71675081
• Device Lot Number: 12JM01287
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 03/18/2020; 06/15/2020
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 03/25/2020; 06/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1