MAUDE Adverse Event Report: ARTHREX, INC.; PLATE, FIXATION, BONE

Device Problem Material Fragmentation (1261)

Patient Problem Pain (1994)

Event Date 09/24/2020

Event Type  Injury  

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 Description

During a removal of hardware procedure as the surgeon was removing the second screw and tip of the ar-8967d 3.5 hex driver broke and the fragments had to be retrieved.A second driver was used to remove the remaining screw.Case was successful.Additional information received on 9/28/2020: the rep reported the reason for the hardware removal procedure was due to painful implanted hardware.A quantity three ar-8967-xxft 6.7 partially threaded screws were removed during the revision surgery.The rep reported the patient was experiencing pain prior to the revision surgery.The explanted devices are not available to return for evaluation, and no arthrex product was implanted during the revision surgery.The rep reported they do not have any information/details regarding the primary surgery.Additional information received on 10/1/2020: the rep reported the specific part number of the explanted screws (ar-8967-xxft) is unknown.The length was not measured and the surgeon did not have a record of the screw length in their surgical notes.Implant record was not available due to (b)(6).

• Brand Name: UNK
• Type of Device: PLATE, FIXATION, BONE
• 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: 10666968
• MDR Text Key: 211264171
• Report Number: 1220246-2020-02232
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/12/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other