MAUDE Adverse Event Report: ARTHREX, INC. INTSCRW RD DELTATPR W/DISP SHTH 9X28MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	INTSCRW RD DELTATPR W/DISP SHTH 9X28MM
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Damage to Ligament(s) (1952)
Date of Event	04/26/2024
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 14th may 2024 it was reported by a arthrex employee via email that when an ar-5028p-09, round delta tapered peek interference screw, with disposable sheath, 9 mm x 28 mm was used, the ligament was cut apart while the anchor was inserted.The anchor was retrieved.This was detected during use in a reconstruction of the posterior cruciate ligament procedure on (b)(6) 2024.The procedure was completed successfully as another brand's product was used.The procedure was delayed for 1 hour and no additional anesthesia was used.Bone quality was good.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Refer to investigation photos.One unpackaged, ar-5028p-09, was received for investigation.Visual evaluation, under a magnifier, noted damage to the head of the screw and damage to the threads.The method of bone preparation employed during the procedure, as well as the bone quality encountered, was not provided.The most likely cause can be attributed to improper bone preparation or prying/leveraging the screw during insertion.

• Brand Name: INTSCRW RD DELTATPR W/DISP SHTH 9X28MM
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: jared engle ; 8009337001
• MDR Report Key: 19497148
• Report Number: 1220246-2024-05353
• Device Sequence Number: 12425296
• Product Code: MAI
• UDI-Device Identifier: 00888867035386
• UDI-Public: 00888867035386
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K062466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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: INTSCRW RD DELTATPR W/DISP SHTH 9X28MM
• Device Catalogue Number: AR-5028P-09
• Device Lot Number: 15115696
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown