MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP INTERFSCRW CAN-DELTATPR 10X35MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	BIO-COMP INTERFSCRW CAN-DELTATPR 10X35MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2022
Type of Reportable Event	Malfunction
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 during an anterior cruciate ligament surgery the device could not be inserted because it was smooth at the tip.Screw could not grip.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update: 15-nov-2022: further information received with the incoming delivery document.The screw has crumbled apart when screwing it in.
Additional Manufacturer Narrative
The complaint is confirmed.One unpackaged ar-5035tc-10, batch number 14937748, was received for investigation.The visual inspection found that loss of geometry at the tip of the screw.The additional visual evaluation found black lines inside the screw as well as signs of wear.The causes remain undetermined.However, the observed condition is most likely the result of interference between the device and other instrumentation or during use.

• Brand Name: BIO-COMP INTERFSCRW CAN-DELTATPR 10X35MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: 15905142
• Report Number: 1220246-2022-05836
• Device Sequence Number: 20342277
• Product Code: MAI
• UDI-Device Identifier: 00888867035515
• UDI-Public: 00888867035515
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Model Number: BIO-COMP INTERFSCRW CAN-DELTATPR 10X35MM
• Device Catalogue Number: AR-5035TC-10
• Device Lot Number: 14937748
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2022
• Supplement Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown