MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN JOURNEY INSTR; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	74012415
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the cutting block adjustment knob and back came off during case.It is unknown how the procedure was finished.It is unknown if there was a delay or if there was any intervention for the adverse event.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection of the returned cutting block confirms the device broke into several pieces.The cutting block, spring, spiked cross bar, cross bar screw and cutting block knob were returned.The posterior ref indicator pin and cup point set screw was not returned with the other pieces.This device was manufactured in 2016.This device exhibits signs of significant wear/usage.A medical investigation was conducted and this case reports that the adjustment knob and back came off of the cutting block during use.A photo of the broken device confirms not all pieces were recovered.Per complaint detail, there was no patient injury reported.It is unknown whether a backup device was required, or if there was a surgical delay.Since there is no patient harm alleged, no further clinical assessment is warranted.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 manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of risk management files found that the reported failure was documented appropriately.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause 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.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: UNKNOWN JOURNEY INSTR
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10832747
• Report Number: 1020279-2020-06414
• Device Sequence Number: 2710805
• Product Code: MDM
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 74012415
• Device Lot Number: 16GM15432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 11/30/2020
• 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: Required Intervention