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

Model Number	72201806
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during a foot and ankle repair surgery, the raptormite anchor broke in the process of hitting with a turning mallet after inserting it.It is unknown if a backup device was available and how the issue was resolved.There was a delay of less than or equal to 30 min.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported that, during a foot and ankle repair surgery, the raptormite anchor broke in the process of hitting with a turning mallet after inserting it.Insertion site had been prepared with a 2.6 mm drill, tuner size 2.6 mm.All pieces removed.The procedure was completed with the same device.There was a delay of less than or equal to 30 min.No other complications were reported.
Additional Manufacturer Narrative
G4, h2, h3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A visual inspection revealed the device was returned with suture and anchor.The anchor is detached from the device.The anchor appears to have damage from being at an angle whenever hit.A functional evaluation revealed the device had no issue actuating and released the suture without hesitation.A review of the drawing found the device must be free of burrs or cracks.A certificate of compliance must be provided with evidence of conformance to material and processing specifications.Based on the condition of the product material found during visual inspection it was determined the device damage was caused by the application of improper/excessive force.Additional material testing is not required.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 review of risk management files found that the reported failure was documented appropriately.The complaint was confirmed.Factors, which could have contributed to the complaint event, include an application of unintended inappropriate or excessive force to the device.

• Brand Name: RAPTORMITE 3.0 PK W/NDL 2 0 ULTRABRA
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11516155
• Report Number: 1219602-2021-00557
• Device Sequence Number: 4046977
• Product Code: MBI
• UDI-Device Identifier: 03596010619082
• UDI-Public: 03596010619082
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K071586
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2021

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: Health Professional
• Device Expiration Date: 09/23/2025
• Device Model Number: 72201806
• Device Catalogue Number: 72201806
• Device Lot Number: 2059727
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 02/24/2021; 04/16/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 04/12/2021; 04/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention