MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,PEEK CRKSCRW FT,TRI-PLAY; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	SUTR ANCH,PEEK CRKSCRW FT,TRI-PLAY
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/22/2019
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 shoulder stabilisation + remplissage procedure, the surgeon inserted two 5.5 corkscrews, ar-1927psf-3, in the humerus.On final insertion of the second anchor, the entire length of the metal tip of the inserter snapped off in the anchor and was unable to be retrieved without compromising the surrounding bone.The anchor was inserted as per the recommended technique.The remplissage was completed as normal with the metal tip to remain in the patient.Unable to determine which batch was used.Either 10318985 or 10327444.

• Brand Name: SUTR ANCH,PEEK CRKSCRW FT,TRI-PLAY
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9506236
• Report Number: 1220246-2019-01523
• Device Sequence Number: 1410629
• Product Code: MBI
• UDI-Device Identifier: 00888867023642
• UDI-Public: 00888867023642
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K143745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/20/2019

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: SUTR ANCH,PEEK CRKSCRW FT,TRI-PLAY
• Device Catalogue Number: AR-1927PSF-3
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 12/20/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other