MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BONE ANCHORS 3 W ARTHRO DEL SYSTEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 2503-A

Device Problems Break (1069); Difficult to Insert (1316); Connection Problem (2900); Material Twisted/Bent (2981); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/13/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event 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.

Manufacturer Narrative

Internal complaint reference (b)(4).

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).

Manufacturer Narrative

Internal complaint reference (b)(4).Correction in h6 (medical device problem code).

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 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
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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
• MDR Text Key: 264921618
• Report Number: 3003604053-2021-00238
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00854501006159
• UDI-Public: 00854501006159
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131635
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/03/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2503-A
• Device Catalogue Number: 4403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention