MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MICRORAPTOR RGNSB SA UB II #1 STR BL CB; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72204984
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Rupture (2208); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during an arthroscopy, the microraptor anchor came off.It is unknown how the issue was solver and a non-significant surgical delay was reported.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
The reported device was received for evaluation.There was a relationship found between the device and the reported event.A complaint history review found similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the polymer found that the storage requirements for the material are specified, and the material must comply with provided percentage composition specifications as measured by ash test.A visual inspection of the returned device found that it is not in its original packaging.The shaft of the insertion device is bent toward the distal end.A small fragment of the fractured anchor was returned, there was no suture material returned.Both the insertion device and the anchor fragment have debris on them.Based on the condition of the product material found during visual inspection, additional material testing is not required.The condition in which the device was received (broken) did not allow for further evaluation of the reported complaint.No relevant supporting clinical information has been provided to assist with a clinical investigation.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.Should any additional clinical information be provided, this complaint will be re-evaluated.The complaint was confirmed, and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device, attempted correction of a damaged device, off-axis insertion, improper preparation of the insertion site, or an inadvertent impact event inconsistent with normal use.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.
Event or Problem Description
It was reported that, during an arthroscopy, the microraptor anchor came off.The device broke inside the patient, all the broken pieces were removed.It is unknown how the issue was solved and a non-significant surgical delay was reported.No further complications were reported.Results of investigation reported that the device was received broken.
Additional Manufacturer Narrative
H2: additional information ¿h10: additional manufacturer narrative¿ h3, h6:the reported device was received for evaluation.There was a relationship found between the device and the reported event.A complaint history review found similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the polymer found that the storage requirements for the material are specified, and the material must comply with provided percentage composition specifications as measured by ash test.A visual inspection of the returned device found that it is not in its original packaging.The shaft of the insertion device is bent toward the distal end.A small fragment of the fractured anchor was returned, there was no suture material returned.Both the insertion device and the anchor fragment have debris on them.Based on the condition of the product material found during visual inspection, additional material testing is not required.The condition in which the device was received (broken) did not allow for further evaluation of the reported complaint.It was communicated that the broken pieces were retrieved from the patient.Since no further risk to the patient is anticipated no further clinical/medical assessment is warranted at this time.The complaint was confirmed, and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device, attempted correction of a damaged device, off-axis insertion, improper preparation of the insertion site, or an inadvertent impact event inconsistent with normal use.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.Corrected data: g4.The previous report (1219602-2022-01111) was sent with an incorrect date received by manufacturer.

• Brand Name: MICRORAPTOR RGNSB SA UB II #1 STR BL CB
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15183826
• Report Number: 1219602-2022-01111
• Device Sequence Number: 20309796
• Product Code: MAI
• UDI-Device Identifier: 00885556710319
• UDI-Public: 00885556710319
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K180361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/05/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/24/2024
• Device Model Number: 72204984
• Device Catalogue Number: 72204984
• Device Lot Number: 2065875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2022
• Supplement Date Received by Manufacturer: 09/20/2022; 01/05/2023
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 12/30/2022; 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown