MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SPYROMITE 2.0 PK W/1 2-0 ULTRABRAID WH; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72201882
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/17/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the device broke when turning it after it was inserted.Backup device was available to complete the procedure.No delay and no patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3,h6: the reported spyromite 2.0 pk w/1 2-0 ultrabraid, used in treatment, has been returned for evaluation.Visual assessment of the device could not confirm the reported breakage.The anchor is bent at its distal end.The condition of the anchor suggests the anchor was subjected to excessive force during insertion causing the reported damage.Per the device instructions for use ¿use of excessive force during insertion can cause failure of the suture anchor or insertion device¿.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: SPYROMITE 2.0 PK W/1 2-0 ULTRABRAID WH
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9580700
• Report Number: 1219602-2020-00076
• Device Sequence Number: 18995962
• Product Code: MBI
• UDI-Device Identifier: 03596010619075
• UDI-Public: 03596010619075
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K081511
• 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): 02/29/2020

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: 12/12/2023
• Device Model Number: 72201882
• Device Catalogue Number: 72201882
• Device Lot Number: 50775489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Initial Date Received by Manufacturer: 12/23/2019
• Supplement Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 02/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1