MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MINITAC 2.0 DURABRAID; STAPLE, FIXATION, BONE

Catalog Number	72200795
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 2.0 minitac ti anchor inserter was returned for evaluation.The anchor and suture were not returned for examination.Examination of the inserter showed no sharp edges or abnormalities that would cause or contribute to suture breakage.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: not retracting the suture tensioning mechanism fully.The instruction for use was reviewed and was found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Event or Problem Description
It was reported that during a finger procedure, when the surgeon inserted the anchor and pulled the suture, the suture fell off the anchor.The procedure was completed with a back-up device so another bone hole was necessary.No patient injury or delay were reported.

• Brand Name: MINITAC 2.0 DURABRAID
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8822096
• Report Number: 1219602-2019-00866
• Device Sequence Number: 18918152
• Product Code: JDR
• UDI-Device Identifier: 03596010585998
• UDI-Public: 03596010585998
• Combination Product (Y/N): N
• PMA/510(K) Number: K972326
• 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
• Report Date (Section B): 07/24/2019

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: 05/06/2023
• Device Catalogue Number: 72200795
• Device Lot Number: 50739656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1