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

Model Number	72202019
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/29/2018
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7886110
• Report Number: 1219602-2018-01283
• Device Sequence Number: 11217437
• Product Code: JDR
• UDI-Device Identifier: 03596010619013
• UDI-Public: (01)03596010619013(17)220227(10)50649746
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K000797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2018

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 09/18/2018
• Supplement Report FDA Received Date: 10/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 50