MAUDE Adverse Event Report: DEPUY MITEK LLC US MILAGRO INTSCR 7X23MM *EA; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Model Number	231800
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the affiliate in (b)(6).That during an anterior cruciate ligament reconstruction procedure on (b)(6) 2022, it was observed that the milagro intscr 7x23mm device remained adhered to the screwdriver.During in-house engineering evaluation, it was determined that the device had marks of use and little spots of biological matter.Another like device was used to complete the procedure with a delay of five minutes.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
Additional narrative: udi: (b)(4).Investigation summary: the complaint device was received and evaluated.Upon visual inspection it could be observed that the screw has marks of use and little spots of biological matter were found.The inserter hexagonal hole is having no structural anomalies.The screw was inserted on a milagro advance inserter tip, the screw did not jam on the inserter.A manufacturing record evaluation was performed for the finished device 4l70087 number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection and test result, this complaint cannot be confirmed.The possible root cause can be attributed to procedural variables, such handling of the device or product interaction during procedure; the driver used on this procedure may was not the adequate, as per ifu 107946; it is mandatory to completely seat the milagro interference screw onto the correct driver for proper implant delivery.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 13685631
• Report Number: 1221934-2022-00761
• Device Sequence Number: 19309203
• Product Code: MAI
• UDI-Device Identifier: 10886705010684
• UDI-Public: 10886705010684
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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 Expiration Date: 04/30/2022
• Device Model Number: 231800
• Device Catalogue Number: 231800
• Device Lot Number: 4L70087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2022
• Initial Report FDA Received Date: 03/07/2022
• Date Device Manufactured: 05/16/2019
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male