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	10/11/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after inserting the anchor it was tested for pullout strength by surgeon and it came out.Surgeon resorted to using competitors anchor to complete repair.No patient injury reported.
Additional Manufacturer Narrative
Investigator determined that complained device worked properly.A visual inspection was performed on the device and no issue was observed.Complaint of video output failure could not be reproduced and device passed functional testing.All device functions performed as expected.Root cause could not be determined since the reported malfunction could not be duplicated during the device evaluation process.A review of the device history records showed there were no indications to suggest that the device did not meet manufacturing specification or would not be able to perform as intended.

• 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: 6946633
• Report Number: 1219602-2017-01293
• Device Sequence Number: 682433
• Product Code: JDR
• UDI-Device Identifier: 03596010619013
• UDI-Public: (01)03596010619013(17)220609(10)50668758
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2017

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: 06/09/2022
• Device Model Number: 72202019
• Device Catalogue Number: 72202019
• Device Lot Number: 50668758
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/11/2017
• Supplement Date Received by Manufacturer: 10/11/2017
• Initial Report FDA Received Date: 10/12/2017
• Supplement Report FDA Received Date: 11/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR