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)
Date of Event	08/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a labral repair procedure, anchor broke.Broken pieces were removed with arthroscopic grasper.No procedural delay or patient injury reported.
Additional Manufacturer Narrative
Microraptor regenesorb sa anchor assembly was returned for evaluation.No anchor was returned only the delivery device.Visual assessment of sample showed no abnormalities.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: 7823512
• Report Number: 1219602-2018-01131
• Device Sequence Number: 1263611
• 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: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2018

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?: Yes
• 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: 08/13/2018
• Supplement Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 10/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR