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

Model Number	OM-7000
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case- (b)(4).
Event or Problem Description
It was reported that the shaft of the speedstitch came off.It is unknown when the event occurred.A back-up device was available and no delays occurred.No patient complications were reported.
Additional Manufacturer Narrative
H10: the information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.Breakage or separation of the handle-to-shaft is unlikely to cause or contribute to serious injury or death.Event may require the surgeon to remove the shaft manually by hand and/or with the use of another tool (e.G.Pliers).Based on the information available, it is unknown if device was being used in a patient when the failure was noticed; however, no medical intervention was reported and a backup device was available to continue with the procedure.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: SPEEDSTITCH DEVICE
• 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: 13142701
• Report Number: 3006524618-2022-00002
• Device Sequence Number: 4577065
• Product Code: GAT
• UDI-Device Identifier: 00817470001402
• UDI-Public: 00817470001402
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2022

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 Model Number: OM-7000
• Device Catalogue Number: OM-7000
• Device Lot Number: H107550
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 01/17/2022
• Initial Report FDA Received Date: 01/03/2022
• Supplement Report FDA Received Date: 01/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown