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

Catalog Number	72204984
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery while inserting the anchor, it broke off.The anchor was held in the bone but they had to retrieve a piece of material.The procedure was completed with a backup device with no delay or patient injury reported.
Additional Manufacturer Narrative
Due to product unavailability, the allegation could not be fully confirmed.Definitive conclusions, investigation and evaluation were not possible without physical evaluation.Factors that may affect device performance include: device storage, device ability, surgical ability, procedure location and tissue condition.Successful implantation is contingent upon following the recommended site prep recommendations and instructions for use.Influences that could compromise product performance or integrity include: 1) use of alternate prep method or instruments.2) unanticipated bone condition resulting in torsional overload or insecurity.3) inability to maintain alignment.4) inability to maintain distal pressure on the inserter.The patient was reported to have soft bone condition.

• Brand Name: MICRORAPTOR RGNSB SA UB II #1 STR BL CB
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8344599
• Report Number: 1219602-2019-00212
• Device Sequence Number: 2010214
• Product Code: MAI
• UDI-Device Identifier: 00885556710319
• UDI-Public: 00885556710319
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2019

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: 08/17/2021
• Device Catalogue Number: 72204984
• Device Lot Number: 50753567
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/31/2019
• Supplement Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 03/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 64