MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72202626
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anchor was cracked during an unknown procedure.The malfunction was solved with no delays or patient harm using a back up device.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10, 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 no relationship found between the subject device and the reported incident.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of the complaint revealed there were no patient injuries reported and no apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.No containment or corrective actions are recommended at this time.

• Brand Name: TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10704666
• Report Number: 1219602-2020-01616
• Device Sequence Number: 19562489
• Product Code: MBI
• UDI-Device Identifier: 03596010647580
• UDI-Public: 03596010647580
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K151105
• 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): 03/22/2021

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: 07/09/2024
• Device Model Number: 72202626
• Device Catalogue Number: 72202626
• Device Lot Number: 50815356
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 03/21/2021
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 03/22/2021
• 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: Other; Required Intervention