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

Model Number	OM-8850
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices reported, used in treatment, were returned for evaluation.A relationship between the device and reported incident was established.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 review of the product/print specifications found material discrepancy used during manufacturing.A visual inspection was performed and found two damaged needles.The complaint is confirmed.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.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.
Event or Problem Description
It was reported that the speedstitch needle failed to pass suture tape.The malfunction happened during an unknown procedure outside the patient; but it was completed using a back up device with no delay or patient injury.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10.Investigation updated: the devices reported, used in treatment, were returned for evaluation.A relationship between the device and reported incident was established.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.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.A review of the product/print specifications found material discrepancy used during manufacturing.A visual inspection was performed and found two damaged needles.The complaint is confirmed and the root cause was associated with 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.A corrective action was initiated to mitigate recurrence of the reported event and a field action was initiated to recall the product.

• 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: 10714899
• Report Number: 3006524618-2020-00901
• Device Sequence Number: 3933756
• Product Code: GAT
• UDI-Device Identifier: 00817470005929
• UDI-Public: 00817470005929
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K042031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2020
• Supplement Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 09/30/2022
• 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 Sex: Unknown