MAUDE Adverse Event Report: DEPUY MITEK LLC US MILAGRO INTSCR 8X23MM *EA; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Model Number	231810
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported by the customer in china that during a posterior cruciate ligament reconstruction procedure on (b)(6) 2021, it was observed that the milagro intscr 8x23mm ea device broke.All the fragments were removed.Another like device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: according to the information provided, it was reported that during the surgery of pcl reconstruction, the anchor was broken off (as the photo shows), removed all the pieces.No additional information could be provided.The product was returned to mitek for evaluation and a photo was provided.Mitek then conducted visual inspection of device received and photo provided by customer.The complaint device was received and inspected.Visual observation indicated that the anchor was broken from the distal part, the external geometry of the screw appeared to be slightly stripped.The photo provided showed the same condition found during the physical evaluation.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.This complaint can be confirmed.No information was provided on how or when the failure has occurred, therefore a definitive root cause could not be determined.The possible root cause can be related when it was off angle or excessive force was used causing the screw to break.For the stripped can be attribute when the screwdriver was not seated properly in the screw head and while attempting the insertion caused the screw treads and or screw head to become stripped / unable to advance.However, it cannot be conclusively affirmed.As per ifu, it is mandatory to completely seat the milagro interference screw onto the correct driver for proper implant delivery.Also, notching and/or tapping are necessary when inserting the interference screw with bone tendon grafts.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Rupture complaint information is consistently analyzed and monitored by quality assurance to determine when further action is necessary.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11345014
• Report Number: 1221934-2021-00586
• Device Sequence Number: 16981129
• Product Code: MAI
• UDI-Device Identifier: 10886705010776
• UDI-Public: 10886705010776
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2021

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: 04/30/2023
• Device Model Number: 231810
• Device Catalogue Number: 231810
• Device Lot Number: 6L94411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 03/12/2021; 03/25/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 03/15/2021; 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1