MAUDE Adverse Event Report: ARTHREX, INC. LOW PROF SCRW,SS 4.0X 50MMCANN LNG THD; SCREW, FIXATION, BONE

Model Number	LOW PROF SCRW,SS 4.0X 50MMCANN LNG THD
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2019
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.
Event or Problem Description
It was reported that during an ankle fracture lateral malleolus procedure the head of the ar-8840cl-50 low profile screw broke off once the body of the screw was in the patient.The rep stated the head of the screw was retrieved, but the body of the screw remains in the patient.It was reported that the body of the screw was still acting as a lateral and medial stabilizer, and even though the screw was no longer applying compression it still served its purpose.There were no attempts made to remove the body of the screw.The rep reported a second surgery is not necessary.Additional information received on 09/23/2019: the rep stated there is not a lot number physically located on the ar-8840cl-50, but the rep believes the screw is from lot: w627551.The retrieved head of the screw is available to return for evaluation.The implant was being placed into the medial malleous.No graft was used.The bone quality was medium to hard.No unplanned incisions were necessary.A 3.0 drill bit was used to prepare the bone.The rep reported there was no attempt to remove the screw because it was still acting as a lateral and medial stabilizer.
Additional Manufacturer Narrative
Complaint was confirmed.A fracture was observed on the underside of the screw.Critical dimensional measurement was performed on the returned device.The device met all specifications as received specifications.The most likely causes are improper bone prep and/or over torqued the screw, when inserting into hard bone.

• Brand Name: LOW PROF SCRW,SS 4.0X 50MMCANN LNG THD
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9178721
• Report Number: 1220246-2019-01344
• Device Sequence Number: 18937162
• Product Code: HWC
• UDI-Device Identifier: 00888867048256
• UDI-Public: 00888867048256
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2019

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: Health Professional
• Device Model Number: LOW PROF SCRW,SS 4.0X 50MMCANN LNG THD
• Device Catalogue Number: AR-8840CL-50
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 10/16/2019
• 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