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

Model Number	231800
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).Investigation summary: according to the information provided, it was reported that during the surgery of acl reconstruction, could not tighten the anchor.Another device was used to complete the surgery.The device was received and evaluated.Visual observations reveals that the device is warped.When reviewing at the hexagonal driver hole, it could be observed that the round surface has an oval look like, therefore, the driver tool cannot not be introduced into the hole.According with the visual inspection result, this complaint can be confirmed.The possible root cause for the distorted condition can be attributed to a mishandling of the device, also accidentally the device could have been stressed on a hard surface with a heavy object leading to a shape distorted condition.However this cannot be conclusively determined.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during an anterior cruciate ligament reconstruction procedure on (b)(6) 2020, it was observed that the milagro intscr 7x23mm ea anchor device could not be tightened.During in-house engineering evaluation, it was determined that the device was warped; and the round surface had an oval look like when reviewing at the hexagonal driver hole.Another like device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.

• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11055958
• Report Number: 1221934-2020-04008
• Device Sequence Number: 2602553
• Product Code: MAI
• UDI-Device Identifier: 10886705010684
• UDI-Public: 10886705010684
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/09/2020

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 Expiration Date: 10/31/2022
• Device Model Number: 231800
• Device Catalogue Number: 231800
• Device Lot Number: 6L41292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1