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

Catalog Number	72203281
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder joint surgery, the anchor broke during implanting, all the pieces were removed from the patient with tweezers, then used a bioraptor as a backup to complete the surgery.No significant delay or patient injury reported.
Additional Manufacturer Narrative
One 2.3 curved bioraptor pk suture anchor was returned for evaluation.The inserter was not returned for examination.Visual assessment of the anchor showed it has broken above the suture eyelet.The distal end of the anchor is also damaged/deformed.The condition of the anchor indicates it was subjected to excessive forces during insertion.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force applied to the device during use.Improper site preparation.The instruction for use was reviewed and was found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• 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: 8952966
• Report Number: 1219602-2019-01066
• Device Sequence Number: 2041564
• Product Code: MBI
• UDI-Device Identifier: 03596010656469
• UDI-Public: 03596010656469
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2019

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: 11/01/2023
• Device Catalogue Number: 72203281
• Device Lot Number: 50767945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 09/01/2019
• Supplement Report FDA Received Date: 09/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1