MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MNITAC,2.0 TI W/NDL,2#2-0 ULTRABRAID; STAPLE, FIXATION, BONE

Model Number 72202019

Device Problem Device Slipped (1584)

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

Event Date 08/29/2018

Event Type  malfunction  

Event Description

It was reported that during the surgery, the screw fell out when implanting.No patient injury was reported.Back-up device was use to completed the surgery.

Manufacturer Narrative

One 2.0 minitac ti anchor was returned for evaluation.Visual assessment of the device showed the anchor and suture are free from the inserter.The needles are free from the suture and were not returned.The anchors threads are heavily damaged making dimensional assessment prohibitive.The insertion device shows no damage.With the limited clinical details provided a root cause cannot be determined.Corrected information.

Event Description

It was reported that during the surgery, the screw fell out when implanting.No patient injury was reported.There was no backup device avalable, the surgery was complete with a competitor device.

• Brand Name: MNITAC,2.0 TI W/NDL,2#2-0 ULTRABRAID
• Type of Device: STAPLE, FIXATION, BONE
• 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: 7886110
• MDR Text Key: 120703655
• Report Number: 1219602-2018-01283
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 03596010619013
• UDI-Public: (01)03596010619013(17)220227(10)50649746
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K000797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2022
• Device Model Number: 72202019
• Device Catalogue Number: 72202019
• Device Lot Number: 50649746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Date Manufacturer Received: 10/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2017
• 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
• Patient Age: 45 YR
• Patient Weight: 50