MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CORTICAL FXATION FXD LOOP 40MM; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	232018
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (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.Patient identifier: (b)(6).Udi: (b)(4).
Event or Problem Description
It was reported via complaint submission tool that during an unknown procedure surgeon was unable to obtain fixation.Rigidloop cortical fixation implant 40 mm would not hold down the tendon.Rep was out of the room at the time but this was relayed to her by the operation room nurse.No surgical delay or patient consequences reported.
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 via complaint submission tool that during an unknown procedure surgeon was unable to obtain fixation.Rigidloop cortical fixation implant 40mm would not hold down the tendon.The complaint device is not being returned, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.Since the complaint device not being returned, we cannot determine a root cause for the reported failure.If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device lot number:l863108, and no non-conformances were identified.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.

• Brand Name: CORTICAL FXATION FXD LOOP 40MM
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10714106
• Report Number: 1221934-2020-03120
• Device Sequence Number: 3259131
• Product Code: MBI
• UDI-Device Identifier: 10886705022694
• UDI-Public: 10886705022694
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2020

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: 04/30/2021
• Device Model Number: 232018
• Device Catalogue Number: 232018
• Device Lot Number: L863108
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 11/25/2020
• Patient Sequence Number: 1