MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE; STAPLE, FIXATION, BONE

Model Number 72201995

Device Problem Break (1069)

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

Event Date 09/15/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that internal to patient, during a dislocation of acromioclavicular joint procedure, the anchor broke and could not be used normally.The pieces were removed from the patient with tweezes.The procedure was completed with non-significant delay using a back-up device in the same bone hole.No patient injury or other complications were reported.

Manufacturer Narrative

H2: additional information ¿b5¿.H3, h6: part of the reported device, was received for evaluation.It was determined the device contributed to the reported event.A complaint history review found similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of polymer found that the storage requirements, material specifications, and applicable tests were appropriately specified.A material certificate of analysis was required for the raw material.A review of the customer provided images found labelling confirming the product identification information.The images show an anchor fractured on the proximal end next to the handheld device.No sutures are pictured.A visual inspection of the returned device found that it is not in its original packaging.The anchor and sutures have not been returned.There is debris on the shaft of the handheld device.Based on the condition of the product material found during visual inspection, additional material testing is not required.Per case details, the broken pieces were retrieved from the patient.The procedure was completed using a backup device.No patient injuries or adverse consequences were reported.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.The complaint was confirmed.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device, attempted correction of a damaged device, off-axis insertion, improper preparation of the insertion site, or an inadvertent impact event.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.

Event Description

It was reported that internal to patient, during a dislocation of acromioclavicular joint procedure, the anchor broke and could not be used normally, all pieces were removed from the patient with tweezes.The procedure was completed with non-significant delay using a back-up device in the same bone hole.No further complications were reported.

• Brand Name: OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12580654
• MDR Text Key: 274904304
• Report Number: 1219602-2021-02217
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 03596010615565
• UDI-Public: 03596010615565
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K151105
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72201995
• Device Catalogue Number: 72201995
• Device Lot Number: 2065324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/15/2021
• Initial Date FDA Received: 10/05/2021
• Supplement Dates Manufacturer Received: 06/24/2022
• Supplement Dates FDA Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2020
• 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
• Patient Weight: 51 KG