MAUDE Adverse Event Report: ARTHREX, INC. IMPLANT SYSTEM, CPR MINI SCORPION DX; SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	IMPLANT SYSTEM, CPR MINI SCORPION DX
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/09/2021
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 not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that the surgery started with the weil¿s osteotomy, then the plantar plate repair.This all went smoothly.Then the surgeon isolated the edb tendon and drilled 2 x 2.5mm holes using the mini biotenodesis disposables set ar-1530ds, he then inserted a 3x8mm biotenodesis screw (ar-1530bc) in the proximal hole which went fine.The surgeon then tried to insert the second screw in using an identical product but the screw would not engage with the tendon and hole.When he had inserted it and tried to disengage the screw driver, the screw came out with the screw driver.He tried this a couple more times until it finally worked.However it was slightly prominent, he went to tighten it and the screw came out again.He had by this point trimmed the tape and suture on the end of the tendon so was unable to tension again to finish that aspect of the procedure.The reported event was a 1st mtp distal phalanx which is a small piece of bone.Then the surgeon tried to insert the quick fix screw from the cpr set.However the quick fix screw did not snap off.After multiple attempts at inserting a twist off screw after a weil¿s osteotomy the bone wasn¿t in good condition anymore.The surgeon reported that the procedure could not be finished as planned and it is unclear if the plantar plate repair is enough to alleviate the patient pain.The following devices were used during the procedure: ar-1530ds-1 lot: 12161979, ar-1530bc lot: 12649748, ar-1530bc lot: 11793696, ar-8930-12s lot: 10574389, ar-8690ds lot: 10300450, ar-8930-11s lot: 10350805, ar-8941ks lot:11790344 x3, ar-7232-03-01 lot: 19272.

• Brand Name: IMPLANT SYSTEM, CPR MINI SCORPION DX
• Common Device Name: SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 12895187
• Report Number: 1220246-2021-04003
• Device Sequence Number: 3485453
• Product Code: GAT
• UDI-Device Identifier: 00888867044692
• UDI-Public: 00888867044692
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/30/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: IMPLANT SYSTEM, CPR MINI SCORPION DX
• Device Catalogue Number: AR-8690DS
• Device Lot Number: 10300450
• 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: 11/10/2021
• Initial Report FDA Received Date: 11/30/2021
• Date Device Manufactured: 04/16/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown