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

Catalog Number	OM-7500
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a tka procedure, when pulling the threads into the anchor, a guide rail did not transport the thread further.This caused the thread to be pulled out of the seam.The speedlock was removed.The procedure was completed with a s+n back up device.The back-up device was used in the originally drilled bone hole no delay and no further complications were reported.
Event or Problem Description
It was reported that during a tka procedure, when pulling the threads into the anchor, a guide rail did not transport the thread further.This caused the thread to be pulled out of the seam.The speedlock was simply removed with the inserter.The procedure was completed with a s+n back up device.The back-up device was used in the originally drilled bone hole no delay and no further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).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.Per additional information received, the backup anchor was used in the same bone hole, therefore no bone voids were left in the patient.Additionally, the faulty anchor was easily removed with the device inserter which does not constitute a medical intervention but standard device use.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: SPEEDLOCK
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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: 12833268
• Report Number: 3006524618-2021-01026
• Device Sequence Number: 4528935
• Product Code: MBI
• UDI-Device Identifier: 00885556724675
• UDI-Public: 885556724675
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2021

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: 07/08/2024
• Device Catalogue Number: OM-7500
• Device Lot Number: 2076825
• 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: 11/02/2021
• Supplement Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 12/02/2021
• 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 Age: 27 YR
• Patient Sex: Male