MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FOOTPRINT ULTRA PK SUTURE ANCHOR, 5.5; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72202902

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 07/23/2018

Event Type  malfunction  

Manufacturer Narrative

One 5.5 footprint ultra pk suture anchor inserter was returned for evaluation.Anchor, stay suture and suture threader were not returned for examination.Visual assessment of the inserter showed the inner shaft has been fully advanced indicating the inner plug of the anchor was advanced for engagement of suture.The inner shaft is soiled with human matter further indicating use within the patient.This investigation could not identify any evidence of product contribution to the reported complaint.

Event Description

It was reported that the device was already off the inserter.Implant was discovered to be loose and off inserter inside patient.Pieces were removed.There was a backup device available to complete the procedure with no delay.No patient injuries reported.

Manufacturer Narrative

(b)(4).

• Brand Name: FOOTPRINT ULTRA PK SUTURE ANCHOR, 5.5
• 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 ; 5123585706
• MDR Report Key: 7791098
• MDR Text Key: 117580153
• Report Number: 1219602-2018-01086
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010650535
• UDI-Public: (01)03596010650535(17)221117(10)50698003
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2022
• Device Model Number: 72202902
• Device Catalogue Number: 72202902
• Device Lot Number: 50698003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2018
• Initial Date FDA Received: 08/16/2018
• Supplement Dates Manufacturer Received: 07/24/2018
• Supplement Dates FDA Received: 08/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2017
• 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