MAUDE Adverse Event Report: ARTHROCARE CORP. SPEEDLOCK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	OM-7500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Case- (b)(4).
Event or Problem Description
It was reported that during a surgery the speedlock anchor cracked while inserting.The procedure was successfully completed without a significant delay using a back-up device.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 h3, h6: the device, used in treatment, was not returned for evaluation.A relationship, if any, between the subject device and the reported event could not be determined since the product was not returned for evaluation.A review of the device history records for the device showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.A review of the instructions for use found the following statement: "do not bend or twist the inserter handle during and after insertion as damage to the implant or incomplete insertion may result.Do not deploy a bent or damaged implant." a review of risk management files found that the reported failure was documented appropriately.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.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: SPEEDLOCK
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 11095565
• Report Number: 3006524618-2020-01166
• Device Sequence Number: 19938976
• Product Code: MBI
• UDI-Device Identifier: 00885556724675
• UDI-Public: 885556724675
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K130196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2021

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: 12/16/2022
• Device Catalogue Number: OM-7500
• Device Lot Number: 2047416
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 02/15/2021
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention