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

Catalog Number	72202019
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a maxillofacial repair surgery, after the device was implanted, the suture broke.The procedure was completed with a back up device with no significant delay or patient injury reported.
Additional Manufacturer Narrative
One 2.0 minitac ti w/needles was returned for evaluation.Visual assessment of the device showed the anchor remains on the inserter.The needles and approximately 1.25 inches of suture attached were returned.The suture appears to have been cut.As reported the device was being utilized in a maxillofacial repair surgery which is considered an off label use.Per the device instructions for use ¿surgical procedure other than those listed on instructions for use are contraindicated¿.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• 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: 9086634
• Report Number: 1219602-2019-01136
• Device Sequence Number: 2592629
• Product Code: JDR
• UDI-Device Identifier: 03596010619013
• UDI-Public: 03596010619013
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2019

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: 10/05/2023
• Device Catalogue Number: 72202019
• Device Lot Number: 50762733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Initial Date Received by Manufacturer: 08/29/2019
• Supplement Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 10/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Weight: 20