MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HAT-TRICK MTP BILATERAL PROC PACK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72204326
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was returned for examination.Visual assessment of the device confirmed one leg of the nitinol loop has come free from the suture passer.The nitinol wire is kinked where it enters the shaft and one leg has broken.The condition of the device indicates excessive force was placed on it during use causing the breakage.As with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure.Use error may have been a contributing factor to the event.A review of the device history record shows there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.Complaint history search revealed no additional complaints for this production lot.This report is being submitted late due to the event description was not clearly understood at the time of receipt.Further review identified this should have been considered reportable per 21cfr 803.Related complaint (b)(4).
Event or Problem Description
The suture retriever from the unilateral kit broke when trying to pull sutures through.A second kit was opened and the same thing happened.They opened the bilateral kit to pull out the suture retriever and used it and it worked.This record is for the second kit.
Additional Manufacturer Narrative
Initial information received, identifed the incorrect manufacturer registered site number (b)(4).The report was based upon information which (b)(4) had not been able to investigate or verify prior to the required reporting date.The correct manufacturer registered site number is (b)(4).

• Brand Name: HAT-TRICK MTP BILATERAL PROC PACK
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 6997591
• Report Number: 1643264-2017-01384
• Device Sequence Number: 19206545
• Product Code: MBI
• UDI-Device Identifier: 00885554034899
• UDI-Public: (01)00885554034899(17)200320(10)50653919
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K133229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2017

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: 03/20/2020
• Device Model Number: 72204326
• Device Catalogue Number: 72204326
• Device Lot Number: 50653919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Initial Date Received by Manufacturer: 08/07/2017
• Supplement Date Received by Manufacturer: 08/07/2017
• Initial Report FDA Received Date: 11/02/2017
• Supplement Report FDA Received Date: 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1