MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CANCELLOUS SELF-TAPPING 6.5MM BONE SCREW 3.0CM LEN; KNEE COMPONENT

Model Number	18080303
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to unknown reasons.
Additional Manufacturer Narrative
The alleged complaint could not be confirmed.The provided incident report states that this patient was revised resulting from "surgeon preference regarding patient condition." microport post market quality contacted the reporting sales representative regarding the possible causes concerning the described patient condition, but the sales representative did not provide any additional information related to this event.Review of the device history record (dhr) for this lot indicates that these products met all established acceptance criteria throughout the manufacturing process.Review of historical complaint data reveals no lot trends for any complaint modes.There is not enough information to investigate this complaint.No information regarding a product failure or any specific complications were made available.This investigation will be reopened if additional information is received.Methods: insufficient information available.Device not returned.Communication/interviews.Results: no findings available.Conclusions: device condition is unknown.Device was used for treatment.Cause not established.
Additional Manufacturer Narrative
Additional information received on 04/21/2023, please void the following report due to this component was not revised and there is not alleged deficiency against the device.

• Brand Name: CANCELLOUS SELF-TAPPING 6.5MM BONE SCREW 3.0CM LEN
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 12908691
• Report Number: 3010536692-2021-00573
• Device Sequence Number: 5085122
• Product Code: HWC
• UDI-Device Identifier: M684180803031
• UDI-Public: M684180803031
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K864626
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: 18080303
• Device Catalogue Number: 18080303
• Device Lot Number: 1802295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/10/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown