MAUDE Adverse Event Report: ARTHREX INC. BIO-COMPOSITE INTERFERENCE SCREW WITH DISPOSABLE SHEATH; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	AR-1380C
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Device history record review revealed nothing relevant to this event.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.This is the first complaint of this type for this part/lot combination.The potential causes of this event are being communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.
Event or Problem Description
It was reported that during an acl procedure the screw broke while inserting between the thread and the head.Part of the screw will remain inside the patient fixed into the bone.According to the surgeon, enough of the screw is left to maintain the ligament on place.No new screw was used and a second surgery was not necessary.
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Device history record review revealed nothing relevant to this event.Complaint confirmed.The evaluation revealed that the screw's thread was broken-off.Complainant's event is typically caused by not inserting the implant co-axial to the bone tunnel, prying or leveraging, improper bone preparation or flexing the joint during insertion.This is the first complaint of this type for this part/lot combination.The potential causes of this event are being communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.
Event or Problem Description
It was reported that during an acl procedure the screw broke while inserting between the thread and the head.Part of the screw will remain inside the patient fixed into the bone.According to the surgeon, enough of the screw is left to maintain the ligament on place.No new screw was used and a second surgery was not necessary.

• Brand Name: BIO-COMPOSITE INTERFERENCE SCREW WITH DISPOSABLE SHEATH
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7137341
• Report Number: 1220246-2017-00484
• Device Sequence Number: 16512039
• Product Code: MAI
• UDI-Device Identifier: 00888867015272
• UDI-Public: 00888867015272
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K071176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2018

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: 05/01/2019
• Device Catalogue Number: AR-1380C
• Device Lot Number: 10146480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 01/19/2018
• 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