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

Model Number	OM-7000
Medical Device Problem Code	Break (1069)
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 speedstitch was broken, no further information.It is unknown whether the event happened during surgery and if there was patient involvement.It is unknown if there was a delay or if a backup device was available and how the issue was resolved.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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.Additional information received by reporter states that by ¿broken device¿ they meant the device was not working as it would not take the needle and not an actual breakage during use.In addition, this failure has not caused serious injuries or death in the past.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
• MDR Report Key: 11782639
• Report Number: 3006524618-2021-00560
• Device Sequence Number: 17058718
• Product Code: GAT
• UDI-Device Identifier: 00817470001402
• UDI-Public: 00817470001402
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2021

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: H109500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1