MAUDE Adverse Event Report: ARTHREX, INC. Ø7X 30MM BC IF SCRW, VENTED; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	Ø7X 30MM BC IF SCRW, VENTED
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via sems that qty.2 of an ar-4030c-08 fastthread¿ biocomposite¿ interference screw 8 x 30 mm and an ar-4030c-07 fastthread¿ biocomposite¿ interference screw 7 x 30 mm had an issue.A surgeon broke these 3 tibial screws, trying to insert them for an acl fixation on (b)(6) 2022.This was discovered during use with no impact to the patient.Additional information has been requested.On (b)(6) 2022, the sales representative stated the following information via email and phone: a tibial drill bit was used to prepare the bone socket for insertion of the implants, the bone quality of the patient was not provided.Pieces of the implants broke off inside the patient and all fragments were retrieved.The case was completed by using one metal interference screw instead, part and lot number were unknown.This prolonged the surgery by about 20 minutes, no additional anesthesia was administered and the case was completed successfully.The outcome seemed to be fine, no patient harm, but the patient will have one metal screw instead of three absorbable ones.
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.

• Brand Name: Ø7X 30MM BC IF SCRW, VENTED
• 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: 13929267
• Report Number: 1220246-2022-04675
• Device Sequence Number: 5158845
• Product Code: MAI
• UDI-Device Identifier: 00888867277649
• UDI-Public: 00888867277649
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K180662
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/28/2022

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: 03/31/2025
• Device Model Number: Ø7X 30MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4030C-07
• Device Lot Number: 13215834
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 03/28/2022
• Date Device Manufactured: 04/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown