MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN PEEK SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72202900

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

Patient Problem Damage to Ligament(s) (1952)

Event Date 02/13/2021

Event Type  Injury  

Event Description

It was reported that on literature review "comparison of single versus double-row techniques in arthroscopic rotator cuff repair of full-thickness tears", 4 patients had a re-tear after a double row rotator cuff repair procedure using a footprint pk anchor.This event was resolved by performing a revision surgery.Patient outcome is unknown.No further information is available.

Manufacturer Narrative

Internal complaint reference case-(b)(4).Article cite: fatih dogar, erdal uzun.Comparison of single versus double-row techniques in arthroscopic rotator cuff repair of full-thickness tears.Ann clin anal med 2021;12(4):422-427.

Manufacturer Narrative

The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.No product identification information was provided and thus a manufacturing record review could not be conducted.A complaint history review concluded this was a isolated event.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 the complaint revealed there were no patient injuries reported and no apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.There was no way to determine if the device contributed to 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 PEEK SUTURE ANCHOR
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, 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: 12917442
• MDR Text Key: 281604092
• Report Number: 1219602-2021-02635
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010652324
• UDI-Public: 03596010652324
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K100159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 72202900
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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