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 a surgery the anchor broke upon insertion.Two anchor broke apart when implanting.The procedure was completed with a backup device with no significant 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.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.Implantation of the suture anchor requires preparation of the insertion site.Predrilling with the appropriate smith and nephew microraptor drill is the preferred method of site preparation.Ensure the anchor placement is aligned with the drilled hole.Proper alignment is essential for successful anchor implantation.Use of excessive force during insertion can cause failure of the suture anchor or insertion device.Bone quality must be adequate to allow proper placement of suture anchor.While maintaining distal pressure on the insertion device, push and/or tap on the proximal end of the insertion device to insert the anchor.Report confirmed that alternate method was used vs.The ifu directive.The patient was reported to have soft bone condition.Comminuted bone surface, which would compromise secure anchor fixation.Final product met specifications upon release to distribution.The second anchor was reported under 1219602-2019-00212.

• 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: 8344581
• Report Number: 1219602-2019-00211
• Device Sequence Number: 11283127
• 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: 05/15/2021
• Device Catalogue Number: 72204984
• Device Lot Number: 50735678
• 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: 18 YR
• Patient Weight: 102