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

Model Number	OM-8850
Medical Device Problem Codes	Failure to Cycle (1142); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).Lot no.: the following are the lot numbers reported: 2104059 and 2111403.However, it is unknown which of the two contributed with the delay greater than 30 minutes.Exp.Date: expiration dates for each of the 2 lots reported: 27-oct-2025 (2104059), 10-jan-2026 (2111403).Mgf.Date: manufacturing dates for each of the 2 lots reported: 27-oct-2022 (2104059), 10-jan-2023 (2111403).
Event or Problem Description
It was reported that two (2) speedstitch needle were not grasping the suture when passing it through the hip capsule.Eventually, the needle tip bent and it was not possible to pass or catch the suture.Surgery was completed after a 45-minute delay, using a slingshot suture passer device from stryker (competitor device).No further complications were reported.
Additional Manufacturer Narrative
H10 h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: SPEEDSTITCH NEEDLE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16976397
• Report Number: 3006524618-2023-00207
• Device Sequence Number: 20439060
• Product Code: GAT
• UDI-Device Identifier: 00817470005929
• UDI-Public: 00817470005929
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023

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-8850
• Device Catalogue Number: OM-8850
• Device Lot Number: 2104059 OR 2111403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2023
• Supplement Date Received by Manufacturer: 11/10/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 11/16/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown