MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 72202901

Device Problem Cut In Material (2454)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Suture was cut when trying to connect to the anchor.A backup device was readily available.There was a delay of less then 30 minutes.No patient injuries were reported.

Manufacturer Narrative

Device investigation narrative - visual inspection and functional testing could not be performed because the device in question was not returned for evaluation.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.There are no indications that would suggest that the device did not meet product specifications upon release into distribution.

Manufacturer Narrative

One 72202901 footprint ultra pk 4.5 mm suture anchor returned.The complaint said ¿the suture was cut when try to connect to the anchor¿.The anchor was not returned.No suture was returned.There were no clinical details provided such as size and method of tap or tunnel, patient bone quality.The device does not show signs of aggressive use.The shaft is straight.The distal inner tip is undamaged and spins concentrically.A functional evaluation was performed and the torque limiter functioned as intended.Audible click was heard with advancement.No root cause related to the manufacturing of this device can be established.No further investigation warranted.

• Brand Name: FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 6692185
• MDR Text Key: 79397821
• Report Number: 1219602-2017-00710
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K093897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2020
• Device Catalogue Number: 72202901
• Device Lot Number: 50554882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1