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

Catalog Number	72204983
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anchor broke.
Event or Problem Description
It was reported that the anchor broke.The device provided adequate fixation despite the small breakage of the anchor.The pieces were removed using mechanical resection.
Additional Manufacturer Narrative
Two microraptor regenesorb sa anchor assemblies were returned for evaluation.No anchors were returned only the delivery devices.Visual assessment of sample (1) showed no abnormalities.Visual assessment of sample (2) showed the distal end of the delivery device where the anchor interfaces is splayed and cracked.Clinical details were provided that stated distal pressure was not maintained on the inserter handle during implantation of the anchor.

• Brand Name: MICRORAPTOR RGNSB SA UB II #1 STR BL
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7935321
• Report Number: 1219602-2018-01380
• Device Sequence Number: 13902619
• Product Code: MAI
• UDI-Device Identifier: 00885556710302
• UDI-Public: (01)00885556710302(17)210515(10)50735677
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/08/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/15/2021
• Device Catalogue Number: 72204983
• Device Lot Number: 50735677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2018
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 10/08/2018; 11/07/2018
• Initial Report FDA Received Date: 10/04/2018
• Supplement Report FDA Received Date: 10/11/2018; 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1