MAUDE Adverse Event Report: ARTHROCARE CORP. SPEEDSTITCH NEEDLE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	OM-8850
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/19/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the speedstitch needle was damaged at the end and would not pass the suture.The procedure was completed with a delay of under 30 min and a backup device was available.No injury to the patient was reported.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 device reported, used in treatment, was not returned for evaluation.A review of manufacturing records for the reported lot number 2047483 found non-conformances or anomalies during manufacturing process related to the reported event.A complaint history review has found related failures.A visual inspection and functional evaluation cannot be performed and customer´s complaint cannot be confirmed.A review of the product/print specifications found material discrepancy used during manufacturing.The factor related to the design or manufacture of the device that lead to the failure reported include, but are not limited to: (1) supplier related issue - failed to provide material that meet specification.The failure is being assessed for recommended actions and further evaluation regarding supplier controls are currently in progress.

• Brand Name: SPEEDSTITCH NEEDLE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 10189336
• Report Number: 3006524618-2020-00410
• Device Sequence Number: 2707034
• Product Code: GAT
• UDI-Device Identifier: 00817470005929
• UDI-Public: 00817470005929
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K042031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2022

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: 01/16/2023
• Device Model Number: OM-8850
• Device Catalogue Number: OM-8850
• Device Lot Number: 2047483
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 07/20/2020; 09/23/2022
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 07/21/2020; 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2999-2020
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Sex: Male