MAUDE Adverse Event Report: DEPUY MITEK LLC US S&W CORT 44MM *EA; LIGAMENT ANCHOR

Model Number	220444
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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 sales rep that after an unknown procedure on (b)(6) 2020, it was observed that a screw device broke inside the patient's body and was removed.There was no surgical delay nor adverse patient consequences reported.No additional information was 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.Investigation summary: background: it was reported by the sales rep via phone that after an unknown procedure one cortical screw, 44mm and one cortical screw, 50mm broke inside the patient´s body and were removed.These devices are available for evaluation.Investigation summary: the s&w cort 44mm ea (part #: 220444, lot #: 1711505) was received and evaluated at us cq.Upon visual inspection, the screw was observed to be broken.Hence, the reported condition can be confirmed.The possible root cause for the reported condition can be that the device encountered unintended forces during its use.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent to which this complaint is observed in the field.
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: device history lot: a manufacturing record evaluation was performed for the finished device [1711505] number, and no non-conformances were identified.

• Common Device Name: LIGAMENT ANCHOR
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11688648
• Report Number: 1221934-2021-01234
• Device Sequence Number: 11496967
• Product Code: HWC
• UDI-Device Identifier: 10886705007271
• UDI-Public: 10886705007271
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K934366
• 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,Followup
• Report Date (Section B): 04/05/2021

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 Model Number: 220444
• Device Catalogue Number: 220444
• Device Lot Number: 1711505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 06/01/2021; 06/04/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 06/02/2021; 06/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1