MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN METAL SUTURE ANCHOR; STAPLE, FIXATION, BONE

Catalog Number UNKNOWN

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

Patient Problems Arthritis (1723); Pain (1994)

Event Date 04/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on literature review results of arthroscopic repair of peripheral triangular fibrocartilage complex tear with exploration of dorsal sensory branch of ulnar nerve, 1 patient suffered postoperative moderate to severe pain at one year after an arthroscopic repair of the peripheral attachment of the tfcc procedure using a minitac device.The patient underwent subsequent sauve-kapanji surgery because of painful arthrosis in distal radioulnar joint.Patient outcome is unknown.No further information is available.

Manufacturer Narrative

H10 h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.Insufficient product identification information was provided and thus a manufacturing record review, complaint history review, risk management review, and an instructions for use/device labeling review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A clinical review states the images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.As of the date of this medical investigation, the requested clinical documentation has not provided; therefore, there were no clinical factors found which would have definitively contributed to the event.The patient outcome and current health status are unknown.Therefore, no further clinical/medical assessment can be rendered.Should any additional clinical information be provided, this complaint may be re-evaluated.There was no relationship found between the device and the reported event.The complaint was not confirmed.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 investigation will be reopened for evaluation.

• Brand Name: UNKN METAL SUTURE ANCHOR
• 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: 15717548
• MDR Text Key: 302883667
• Report Number: 1219602-2022-01663
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K972326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2022
• 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): Other