MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BONE ANCHORS 3 W ARTH DEL SYS; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	2503-A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during surgery, when the tendon anchors were being inserted into the tendon anchor inserter they broke.The procedure was successfully completed without significant delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported device, used in treatment, was not returned for evaluation.Thus visual inspection and functional testing could not be performed.No product identification information was provided and thus a manufacturing record review and complaint history review could not be conducted.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: BONE ANCHORS 3 W ARTH DEL SYS
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10990993
• Report Number: 1219602-2020-02038
• Device Sequence Number: 792466
• Product Code: MBI
• UDI-Device Identifier: 00854501006173
• UDI-Public: 00854501006173
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K131635
• 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): 01/12/2021

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 Model Number: 2503-A
• Device Catalogue Number: 2503-A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 12/11/2020
• Supplement Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1