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

Model Number	OM-8850
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a hip arthroscopy with labral repair, the speedstitch needle broke off in the patient and not all the pieces were removed.The procedure was successfully completed with a 30 min delay using a back-up device.No patient complications were reported.It is unknown how the procedure was finished or if there was a surgical delay.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H2: additional information in b5 & h6 (health effect - impact code).H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of device records showed 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.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.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.The broken needle is comprised of 304 stainless steel spring wire and it is not intended for long-term implantation.Since we are unable to determine the location of the retained pieces, we cannot rule the possibility of micro-motion/migration of the retained pieces.Therefore, no further clinical/medical assessment is warranted at this time.Should any additional relevant clinical information be provided, this case would be re-assessed.There was no relationship found between the device and the reported event.The complaint was not confirmed.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.
Event or Problem Description
It was reported that during a hip arthroscopy with labral repair, the speedstitch needle broke off in the patient and not all the pieces were removed.The procedure was successfully completed with a 30 min delay using a back-up device.No patient complications were reported.No further complications were reported.

• 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: 12968557
• Report Number: 3006524618-2021-01052
• Device Sequence Number: 4394979
• Product Code: GAT
• UDI-Device Identifier: 00817470005929
• UDI-Public: 00817470005929
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/08/2024
• Device Model Number: OM-8850
• Device Catalogue Number: OM-8850
• Device Lot Number: 2076836
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2021
• Supplement Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 12/09/2021
• Supplement Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown