MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,CRKSCRW; SCREW, FIXATION, BONE

Model Number	SUTR ANCH,CRKSCRW
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/19/2020
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.
Event or Problem Description
It was reported that during a patellar tendon suture the metal tip broke off inside the patient.The surgeon tried to retrieve the part out of the patient but was not successful.The piece remained inside the patient.The surgery was finished successfully with the same device anyway.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint confirmed, the screw broke off in two pieces, with the proximal end fragment remaining in the driver cannulation.Likely causes include improper bone prep, misaligned insertion, prying/leveraging the device during insertion.

• Brand Name: SUTR ANCH,CRKSCRW
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9700828
• Report Number: 1220246-2020-01663
• Device Sequence Number: 19268148
• Product Code: HWC
• UDI-Device Identifier: 00888867022669
• UDI-Public: 00888867022669
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2020

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: 02/29/2024
• Device Model Number: SUTR ANCH,CRKSCRW
• Device Catalogue Number: AR-1915SF-1
• Device Lot Number: 10293083
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 04/01/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other