MAUDE Adverse Event Report: ARTHREX, INC. SPEED C" CRVED NDL W/2PEEK IMP & 2-0 FW; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	SPEED C" CRVED NDL W/2PEEK IMP & 2-0 FW
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was expected but was not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported by the rep that during the case, after the first implant deployed, the handle fell apart.The first anchor remains in the soft tissue; the second anchor was not deployed.A competitor's device was used to complete the case.Patient is a (b)(6) year old female.
Additional Manufacturer Narrative
Complaint cannot be confirmed.Visual evaluation revealed no damage to the individual components, handle, or mating pegs or holes of the handle of the disassembled device.During testing, the handle halves mated securely without the internal components installed.There was no glue residue noted on the handle pegs or corresponding holes, which could have contributed to the reported event.Both implants were present on the returned device; therefore no implant had been left in the patient as reported.

• Brand Name: SPEED C" CRVED NDL W/2PEEK IMP & 2-0 FW
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7629117
• Report Number: 1220246-2018-00523
• Device Sequence Number: 16502063
• Product Code: GAT
• UDI-Device Identifier: 00888867102675
• UDI-Public: 00888867102675
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K132043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2019

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?: No
• Operator of Device: No Information
• Device Model Number: SPEED C" CRVED NDL W/2PEEK IMP & 2-0 FW
• Device Catalogue Number: AR-4502
• Device Lot Number: F184670
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 06/11/2018
• Initial Report FDA Received Date: 06/22/2018
• Supplement Report FDA Received Date: 02/21/2019
• 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: Other