MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ULTRA FAST-FIX ASSEMBLY - CURVED; STAPLE, FIXATION, BONE

Model Number 72201491

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/08/2018

Event Type  malfunction  

Event Description

It was reported that during a cl repair procedure under a arthroscope, there was only one t after opening the carton.No patient injury was reported.

Manufacturer Narrative

One 72201491 ultra-fast-fix needle delivery system device returned.The device was used for an arthroscopic cruciate ligament repair.The complaint said: ¿it was reported that during a cl repair procedure under an arthroscope, there was only one t after opening the carton.¿ the blue split cannula was returned protecting the needle tip.The depth limiter was returned trimmed.T1, t2 and suture were returned but separated from the device.The device shows signs of use.There is surgical matter attached to the suture and t2.T2 has had the suture cinched; as with use.T1 is absent.T1 suture location has a knot but the end is severed.The actuator slide lever has been fully advanced which indicates advancement and positioning of t1 and t2 for stripping off.The needle shaft is straight.The device was not returned in as sold condition.If a defect is observed, the device should be returned as found.No root cause related to the manufacture of the device was established.No further investigation is warranted.

• Brand Name: ULTRA FAST-FIX ASSEMBLY - CURVED
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7341737
• MDR Text Key: 102732446
• Report Number: 1219602-2018-00338
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 03596010597205
• UDI-Public: (01)03596010597205(17)220131(10)50644497
• Combination Product (y/n): N
• PMA/PMN Number: K972326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 72201491
• Device Catalogue Number: 72201491
• Device Lot Number: 50644497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 65