MAUDE Adverse Event Report: ARTHREX INC. SUTURE ANCHOR BIO-COMPOSITE SUTURE-TAK KNOTLESS; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	AR-1938BC
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (date of birth, 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.An evaluation of the device cannot be performed as the device was discarded by the facility.Additional information has been requested but not made available.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Device history record review revealed nothing relevant to this event.This is the first complaint of this type for this part/lot combination.The potential causes of this event are being communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a slap procedure, after the surgeon inserted the 3.0 bio-composite knotless suture tak into the glenoid, he began to pull traction with the suture and the top portion of the anchor pulled out.The distal portion of the anchor remained in the patient's glenoid.No further details have been given but additional information has been requested.Patient is a male, (b)(6).Follow-up investigation: a little more than 3/4 of the suture tak was left in the glenoid.Another suture tak was used and placed next to the first one.The same drill bit was used for both suture taks.No additional unplanned incision was made, the surgeon used the same portal.The top portion of the ar-1938bc suture tak is being returned for evaluation.

• Brand Name: SUTURE ANCHOR BIO-COMPOSITE SUTURE-TAK KNOTLESS
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7070098
• Report Number: 1220246-2017-00459
• Device Sequence Number: 13749643
• Product Code: MBI
• UDI-Device Identifier: 00888867097186
• UDI-Public: 00888867097186
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K120155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/30/2017

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 Expiration Date: 11/15/2017
• Device Catalogue Number: AR-1938BC
• Device Lot Number: 10161007
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2017
• Initial Report FDA Received Date: 11/30/2017
• 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
• Patient Age: 27 YR