MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RAPTORMITE 3.0 PK W/NDL, 2 #0 ULTRABRA; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72201806

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Subcutaneous Nodule (4548); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that after a repair ligament ankle with four(4) raptormite anchors (case-(b)(4) /lot #2080566); (case-(b)(4) / lot#2065615); (case-(b)(4) /lot#2078872); (case-(b)(4) / lot#2075624).The patient had an unspecified adverse reaction.It is unknown how the event was treated.

Manufacturer Narrative

H10: h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.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.There was no relationship found between the device and the reported event.The complaint was not confirmed.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.Corrected data: b1, b2, b5.

Event Description

It was reported that after a repair ligament ankle with a raptormite anchor the patient had an unspecified adverse reaction.It is unknown how the event was treated.

Event Description

It was reported that, after a repair ligament ankle with four (4) raptormite anchors (case-(b)(4) /lot #2080566); (case-(b)(4)/ lot#2065615); (case-(b)(4) /lot#2078872); (case-(b)(4)/ lot#2075624).The patient developed a sub cutaneous response around her two ankle incisions where the patient has two anchors placed on each side in association with a ligament reconstruction, then the patient developed a systemic response, that was worked up by an allergy an dermatology specialist who concluded it was a reaction to the peek anchors.It was requested to remove it, as per this, all the four anchor were removed.The patient appears to be doing better since their removal and the systemic response is now absent.

Manufacturer Narrative

H10: internal complaint reference: case (b)(4).

Manufacturer Narrative

Internal complaint reference: (b)(4).H10 h3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.The instructions for use were 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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: RAPTORMITE 3.0 PK W/NDL, 2 #0 ULTRABRA
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, 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: 15169057
• MDR Text Key: 297312021
• Report Number: 1219602-2022-01098
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010619082
• UDI-Public: 03596010619082
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72201806
• Device Catalogue Number: 72201806
• Device Lot Number: 2065615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other