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 Known Impact Or Consequence To Patient (2692)
Date of Event	06/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a foot and ankle surgery, the anchor tip of the raptormite was exposed on the inner plastic sheet, and it was found to be broken.The procedure was successfully completed without significant delay using the same device.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10 h3,h6: one 72201806 raptormite 3.0pk with needle single use device used for treatment, was returned for evaluation.The device had a damaged anchor.All components are present.Anchor and four needles are still attached to suture.The anchor was free from the insertion device.It was slightly bent and visibly cracked open from the proximal end.This symptom is consistent with the insertion device losing axial alignment and excess torque applied.Instructions for use includes recommendations and precautionary statements and for proper use of product.Per instructions for use: ¿use of approved smith and nephew instrumentation is strongly recommended to prepare the insertion site and maintain axial alignment between insertion site and the raptormite¿ suture anchor.Breakage of the suture anchor can occur if the insertion site is not prepared with the recommended smith and nephew drill prior to implantation.Only use the appropriate drill bits and drill guides intended for use with the raptormite¿ suture anchor or the implant may not be properly aligned.Note: when using raptormite 3.0 mm or 3.7 mm suture anchors, use a smith and nephew drill guide and a drill bit (each sold separately) specific to the suture anchors to prepare the insertion site.¿ instructions for use contains recommendations and precautionary statements for proper use of product.Risk management files contain the reported failure.

• 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: 10262164
• Report Number: 1219602-2020-01015
• Device Sequence Number: 19698647
• 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
• Report Date (Section B): 08/07/2020

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 Expiration Date: 01/15/2025
• Device Model Number: 72201806
• Device Catalogue Number: 72201806
• Device Lot Number: 2048185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 07/12/2020
• Supplement Report FDA Received Date: 08/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 70