MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIORAPTOR CRV 2.3 PK SA UB COBRD BLUE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72203281
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/11/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder joint surgery the bioraptor broke while it was implanting.The anchor was removed from the patient and the same hole was used to implant a backup bioraptor.No significant delay or patient injury reported.
Additional Manufacturer Narrative
The device was used for a ¿shoulder joint surgery¿.It was returned with the anchor and one suture attached to the anchor.The anchor is threaded, but separated from the shaft.The anchor is sheared after the second barb at the eyelet.The inserter is visibly bent.At the damaged location, there are dings and circular bands of scratches around the shaft.The sliding ring/compression spring is functional.Pre-drilling was confirmed, but not what instrument was used.Symptoms indicate loss of axial alignment during insertion.The ifu cautions: ¿ensure that the anchor placement is aligned with the drilled hole.Proper alignment is essential for successful repair.Establish and maintain axial alignment of the suture anchor with the prepared insertion site.Caution: ensure that the anchor placement is aligned with the drilled hole.Proper alignment is essential for successful repair.Establish and maintain axial alignment of the suture anchor with the prepared insertion site.¿ no root cause associated with the manufacture of this device could be supported.

• Brand Name: BIORAPTOR CRV 2.3 PK SA UB COBRD BLUE
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 6972751
• Report Number: 1219602-2017-01325
• Device Sequence Number: 444200
• Product Code: MBI
• UDI-Device Identifier: 03596010656469
• UDI-Public: (01)03596010656469(17)220131(10)50644570
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K102660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2017

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: 01/31/2022
• Device Model Number: 72203281
• Device Catalogue Number: 72203281
• Device Lot Number: 50644570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2017
• Initial Date Received by Manufacturer: 10/19/2017
• Supplement Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 10/24/2017
• Supplement Report FDA Received Date: 12/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR