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

Model Number	72204325
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 the nitinol loop has come free from the suture passer and was not returned for evaluation.The shaft of the suture passer is dramatically bent at its proximal end.A review of the complaint data associated for this product confirmed this failure mode to be isolated in nature.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.We then opened the bilateral kit to pull out the suture retriever and used it and it worked.This record is for the first kit.

• Brand Name: HAT-TRICK MTP UNILATERAL PROC PACK
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 6997592
• Report Number: 1219602-2017-01361
• Device Sequence Number: 13575221
• Product Code: MBI
• UDI-Device Identifier: 00885554034882
• UDI-Public: (01)00885554034882(17)180630(10)50555426
• 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
• Report Date (Section B): 11/02/2017

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: 06/30/2018
• Device Model Number: 72204325
• Device Catalogue Number: 72204325
• Device Lot Number: 50555426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2017
• Initial Report FDA Received Date: 11/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1