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

Model Number	2503-A
Medical Device Problem Codes	Break (1069); Difficult to Insert (1316); Connection Problem (2900); Material Twisted/Bent (2981); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, during surgery, the inserter was not loading the anchors from the puck correctly and a the anchor broke.Although a back-up device was available to complete the procedure, it is unknown if there was a surgery delay.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
Internal complaint reference (b)(4).Correction in h6 (medical device problem code).
Additional Manufacturer Narrative
H10: internal complaint reference: case-(b)(4).Correction in d1, d2, d4 (catalog & udi no's), g4 (510k) & h6 (medical device problem code).
Additional Manufacturer Narrative
H10: h2: additional information on: b5 & e1.H3, h6: the reported device was received for evaluation.A visual inspection found that one of the tines are slightly bent.A functional evaluation revealed that the device can not properly load a tendon anchor due to the bent tine.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause has been associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device tip, attempted correction of a damaged device, or an inadvertent impact event.No containment or corrective actions are recommended at this time.H11: h2: corrected data on: d1, d2a, d4, g4, h4 & h6 (health effect - impact code).
Event or Problem Description
It was reported that, during a revision rcr surgery, the tendon anchor inserter was not loading the anchors from the puck correctly.The procedure was successfully completed with a 30 minutes surgical delay using a back-up device.No further complications were reported.

• Brand Name: BONE ANCHORS 3 W ARTHRO DEL SYSTEM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12271210
• Report Number: 3003604053-2021-00238
• Device Sequence Number: 14670982
• Product Code: MBI
• UDI-Device Identifier: 00854501006173
• UDI-Public: 00854501006173
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K131635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/03/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/05/2023
• Device Model Number: 2503-A
• Device Catalogue Number: 2503-A
• Device Lot Number: 2063706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 07/14/2021; 11/07/2022; 11/07/2022; 12/26/2023
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 08/03/2021; 11/07/2022; 11/08/2022; 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown