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

Catalog Number	OM-8850
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/13/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that when the surgeon was performing a hip scope, a speedstitch needle broke inside the patient.The procedure was successfully completed without significant delay using a competitor device.No 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 h3,h6: the device reported, used in treatment, was not returned for evaluation.Although the device is not available, a relationship between the product and reported incident is possibly established and the complaint is more than likely confirmed as the event reported matches an issue identified during manufacturing of the device.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.Review of the product ifu found adequate warnings and precautions to prevent damage to the device during use.Risk management documents were reviewed finding no additional risks that require to be added to the reference document.A review of the product/print specifications found material discrepancy used during manufacturing.Clinical/medical evaluation was completed and concluded that based on the information provided, the root cause of the reported breakages are the needles being made of incorrect material vs the design 304 spring wire stainless steel.Although titanium has been proven implantable, this externally communicating device was not manufactured or intended for implantation.If the needles were retained the impact to the patient beyond possible local irritation and/or discomfort, micromotion/or migration, and additional radiological imaging/exposure cannot determined.No further assessment is warranted at this time.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.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: the device reported, used in treatment, was not returned for evaluation.Although the device is not available, a relationship between the product and reported incident is possibly established and the complaint is more than likely confirmed as the event reported matches an issue identified during manufacturing of the device.A review of manufacturing records for the reported lot number found non-conformances or anomalies during manufacturing process related to the reported event.A complaint history review has found related failures.Review of the product ifu found adequate warnings and precautions to prevent damage to the device during use.Risk management documents were reviewed finding no additional risks that require to be added to the reference document.A review of the product/print specifications found material discrepancy used during manufacturing.Clinical/medical evaluation was completed and concluded that based on the information provided, the root cause of the reported breakages are the needles being made of incorrect material vs the design 304 spring wire stainless steel.Although titanium has been proven implantable, this externally communicating device was not manufactured or intended for implantation.If the needles were retained the impact to the patient beyond possible local irritation and/or discomfort, micromotion/or migration, and additional radiological imaging/exposure cannot determined.No further assessment is warranted at this time.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.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.A corrective action was initiated to mitigate recurrence of the reported event and a field action was initiated to recall the product.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).Correction in h10 (complaint no.Updated).

• Brand Name: SPEEDSTITCH NEEDLE CASSETTE INSERT
• 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: 10131073
• Report Number: 3006524618-2020-00343
• Device Sequence Number: 13903353
• Product Code: GAT
• UDI-Device Identifier: 00817470005929
• UDI-Public: 817470005929
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/30/2022

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: 01/16/2023
• Device Catalogue Number: OM-8850
• Device Lot Number: 2047483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 07/27/2020; 09/23/2022; 09/23/2022
• Initial Report FDA Received Date: 06/08/2020
• Supplement Report FDA Received Date: 07/30/2020; 09/29/2022; 10/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown