MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MNITAC 2.0 TI W/NDL 22-0 ULTRABRAID; STAPLE, FIXATION, BONE

Model Number	72202019
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during a surgery the mnitac 2.0 titanium neddles bent and broke while trying to pass the suture.They cut the suture and used a free needle.No delay was reported.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was a relationship found between the subject device and the reported incident.An analysis of the customer provided image revealed that at least two needles had bent enough that continued use of them would not have been advisable.The needles that bent had been cut away.A review of the device records showed there were no indications to specification or would not be able to perform as intended.A complaint history re-suggests that the product did not meet manufacturing specw concluded this was an isolated event.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found the following warnings and precautions related to the reported failure: read these instructions completely prior to use.Prior to use, inspect the device to ensure it is not damaged.Do not use a damaged device.The complaint was confirmed, and the root cause was associated with component failure.Factors that could have contributed to the reported event include prolonged use of the single use needles, greater force or torque than anticipated for the device, or inability to withstand anticipated forces.

• Brand Name: MNITAC 2.0 TI W/NDL 22-0 ULTRABRAID
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11283738
• Report Number: 1219602-2021-00264
• Device Sequence Number: 3544117
• Product Code: JDR
• UDI-Device Identifier: 03596010619013
• UDI-Public: 03596010619013
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K000797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/20/2025
• Device Model Number: 72202019
• Device Catalogue Number: 72202019
• Device Lot Number: 2053766
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention