MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, BIO-COMPOSITE SUTURETAK; SCREW, FIXATION, BONE

Catalog Number	AR-1934BCF
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.No device malfunction can be identified.At this time, it cannot be determined how the device may have caused or contributed to the incident.An evaluation of the device cannot be performed as the device remained in the patient.Additional information was not made available.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Lot number was not provided therefore device history record cannot be investigated.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.Device remains in patient.
Event or Problem Description
It was reported that during a shoulder instability case, the 3.0 bio-composite suturetak suture anchor, ar-1934bcf, broke out of the glenoid neck.The surgeon was able to remove the suture material however, the anchor could not be seen as it was enveloped within the capsular tissue.The surgeon felt it was too risky to work medially to find it.Therefore, the anchor was left imbedded within the capsular tissue and was not removed.

• Brand Name: SUTURE ANCHOR, BIO-COMPOSITE SUTURETAK
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6431384
• Report Number: 1220246-2017-00080
• Device Sequence Number: 10897021
• Product Code: HWC
• UDI-Device Identifier: 10888867023878
• UDI-Public: 10888867023878
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K082810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/24/2017

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 Catalogue Number: AR-1934BCF
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other