MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX 3.5 TI ANC W/ ULTB SUTURE W/NEED; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72203784
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during a surgery, some of the twinfix needles fell off when used inside the patient.The procedure was successfully completed without a significant delay using the same device.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
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.No product identification information was provided and thus a manufacturing record review could not be conducted.A complaint history review concluded this was a repeat issue.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: ¿- prior to use, inspect the device to ensure it is not damaged.Do not use a damaged device.- do not use sharp instruments to manage or control the suture.¿ a clinical investigation concluded that without the relevant clinical information such as radiographs or an operative report the root cause of the reported issue could not be determined.No response was received for if the needles were retained or removed from the patient so it cannot be confirmed that they are not left as a foreign body.If the needles were retained, they are non-implantable, therefore, impact to the patient beyond the possibility of corrosion, local irritation/discomfort, and/or migration of the possible retained needles cannot be determined.It was reported the procedure completed without a significant delay or patient harm with the same device.Since there were no other complications reported, no further clinical/medical assessment is warranted at this time.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: TWINFIX 3.5 TI ANC W/ ULTB SUTURE W/NEED
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11336975
• Report Number: 1219602-2021-00336
• Device Sequence Number: 11895237
• Product Code: MBI
• UDI-Device Identifier: 00885554029277
• UDI-Public: 00885554029277
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K123425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2021

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 Model Number: 72203784
• Device Catalogue Number: 72203784
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/26/2021
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 04/09/2021
• 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