MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OSTEORAPTOR 2.3 W. UB COBRAID BLUE; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number 72201993

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Discomfort (2330)

Event Date 10/18/2023

Event Type  Injury  

Event Description

It was reported that after a reconstruction of the extensor tendon using an osteoraptor anchor, the patient had an exposed band suture absorbable bone anchor nail in the right ring finger and a small exposed suture at the dorsal skin of the middle knuckle of the ring finger.The anchor was removed, and a debridement of the right ring finger was performed.The patient has returned to his home for recuperation, no further complications were reported.

Manufacturer Narrative

Internal complaint reference (b)(4).

Manufacturer Narrative

H10: h3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined due to the limited clinical information provided.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.The instructions for use were 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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states that it is likely that the root cause that led to the reported event was multi-factorial given the reported discomfort and patient finding of the ¿wound was broken¿ approximately 1.5 months post suture anchor implantation and requiring debridement.It is unknown if the patient adhered to the post-operative instructions or if the anchor site was prepped according to the ifu recommendations.A surgical technique/user variance therefore is a likely contributing factor in the placement of the suture and knots.The patient impact included the reported ¿wound was broken¿/exposed anchor/suture and discomfort with subsequent anchor removal with wound debridement along with an anticipated transient post-surgical restoration phase.It is unknown if there was a dip extensor tendon deficit recurrence post-suture anchor removal; however, the patient was reportedly discharged home for recuperation with no further complications reported.Based on the limited information provided a thorough medical assessment could not be performed; therefore, we are unable to conclude on specific factors known to contribute to the alleged report.No containment or corrective actions are recommended at this time.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined due to the limited clinical information provided.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.The instructions for use were 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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states that it is likely that the root cause that led to the reported event was multi-factorial given the reported discomfort and patient finding of the ¿wound was broken¿ approximately 1.5 months post suture anchor implantation and requiring debridement.It is unknown if the patient adhered to the post-operative instructions or if the anchor site was prepped according to the ifu recommendations.A surgical technique/user variance therefore is a likely contributing factor in the placement of the suture and knots.The patient impact included the reported ¿wound was broken¿/exposed anchor/suture and discomfort with subsequent anchor removal with wound debridement along with an anticipated transient post-surgical restoration phase.It is unknown if there was a dip extensor tendon deficit recurrence post-suture anchor removal; however, the patient was reportedly discharged home for recuperation with no further complications reported.Based on the limited information provided a thorough medical assessment could not be performed; therefore, we are unable to conclude on specific factors known to contribute to the alleged report.No containment or corrective actions are recommended at this time.

• Brand Name: OSTEORAPTOR 2.3 W. UB COBRAID BLUE
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: 18162431
• MDR Text Key: 328428972
• Report Number: 1219602-2023-02244
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 03596010615541
• UDI-Public: 03596010615541
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 72201993
• Device Lot Number: 2072967
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2021
• 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; Other
• Patient Age: 42 YR
• Patient Sex: Female