MAUDE Adverse Event Report: CONMED UTICA GENESYS MATRYX 7.0 X 30 MM INTERFERENCE SCREW; SCREW, FIXATION, BONE

Model Number	237030M5
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the device 237030m5, genesys matryx 7.0 x 30 mm interference screw was being used on (b)(6) 2022 during a lateral collateral ligament & medial collateral ligament procedure when it was reported ¿when the doctor took an x-ray after the surgery, our screw was out of its tunnel.¿ further assessment found that on (b)(6) 2022 an x-ray was taken post operatively and discovered that the screw pulled out and did not fragment.The second operation was performed on (b)(6) 2022, and the surgeon removed the displaced screw and replaced it with a ¿genesys screw 8x35 mm screw¿.The procedure was completed with no report of delay.There was an extended hospitalization of two days for the patient.It was also reported that ¿the patient is fine".This report is being raised on the basis of injury due to the report of screw pull-out of its tunnel and a second operation being performed.
Additional Manufacturer Narrative
Reported event ¿screw pull-out¿ is inconclusive.The device is not being returned and the photographic evidence provided does not appear to confirm or unconfirm the event; therefore, a device malfunction cannot be verified.If the device is returned, at a later date, the investigation may be updated and reanalyzed.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.(b)(4).Per the ifu, th user is advised: the surgeon must choose proper screw size based on specific procedure and patient history.The screw must be fully inserted below the cortical surface to avoid protrusion and soft tissue irritation.Improper insertion technique may cause breakage of the screw and/or driver or premature failure.Until ligament healing is complete, all fixation achieved with this screw should be considered as only temporary and may not withstand weight bearing or other unsupported stresses.Premature bending, loosening, fracture or migration of the screws may result from early stress and activity.Appropriate immobilization/controlled mobilization should be used until clinical determination of ligament healing.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the device 237030m5, genesys matryx 7.0 x 30 mm interference screw was being used on (b)(6) 2022 during a lateral collateral ligament & medial collateral ligament procedure when it was reported ¿when the doctor took an x-ray after the surgery, our screw was out of its tunnel.¿ further assessment found that on (b)(6) 2022 an x-ray was taken post operatively and discovered that the screw pulled out and did not fragment.The second operation was performed on (b)(6) 2022, and the surgeon removed the displaced screw and replaced it with a ¿genesys screw 8x35 mm screw¿.The procedure was completed with no report of delay.There was an extended hospitalization of two days for the patient.It was also reported that ¿the patient is fine".This report is being raised on the basis of injury due to the report of screw pull-out of its tunnel and a second operation being performed.

• Brand Name: GENESYS MATRYX 7.0 X 30 MM INTERFERENCE SCREW
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: samantha dewberry ; 525 french rd; utica, NY 13502 ; 3152230184
• MDR Report Key: 15085852
• Report Number: 1320894-2022-00162
• Device Sequence Number: 4055613
• Product Code: HWC
• UDI-Device Identifier: 10845854016961
• UDI-Public: (01)10845854016961(17)221220(30)1(10)201712211
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K052080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2022

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 Expiration Date: 12/20/2022
• Device Model Number: 237030M5
• Device Catalogue Number: 237030M5
• Device Lot Number: 201712211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2022
• Supplement Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic