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

Catalog Number	AR-1934PS
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Device history record review revealed nothing relevant to this event.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.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 additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a shoulder procedure the ar-1934ps anchor broke.The broken part remains in the patient flush with the bone and not protruding.The surgeon implanted another one next to it and it worked fine.During the same procedure surgeon was implanting another ar-1934ps on another spot and the same event occurred, the anchor broke.He drilled again next to it and once again the second implant held.The case was completed with no further issues.Additional information obtained 1/8/2018: the procedure was a rotator cuff/labrum repair.The incident occurred on the labrum.As the surgeon as pushing down his knot, a pop was heard, and the suture appeared to rip out of the anchor.The suture was intact and there were no visible fragments of the anchor in the joint space or in the labrum.The pulled out suture was then cut before inserting different anchors.No parts are available to return to arthrex except remaining unopened anchors from the same lot which will be returned.
Event or Problem Description
It was reported that during a shoulder procedure the ar-1934ps anchor broke.The broken part remains in the patient flush with the bone and not protruding.The surgeon implanted another one next to it and it worked fine.During the same procedure surgeon was implanting another ar-1934ps on another spot and the same event occurred, the anchor broke.He drilled again next to it and once again the second implant held.The case was completed with no further issues.Additional information obtained 1/8/2018: the procedure was a rotator cuff/labrum repair.The incident occurred on the labrum.As the surgeon as pushing down his knot, a pop was heard, and the suture appeared to rip out of the anchor.The suture was intact and there were no visible fragments of the anchor in the joint space or in the labrum.The pulled out suture was then cut before inserting different anchors.No parts are available to return to arthrex except remaining unopened anchors from the same lot which will be returned.
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.This is a follow-up submission.The actual device was not returned.Device history record review revealed nothing relevant to this event.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.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 additional relevant information is received, a follow-up report will be submitted.

• Brand Name: SUTURE ANCHOR, PEEK SUTURETAK
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7205649
• Report Number: 1220246-2018-00001
• Device Sequence Number: 11056052
• Product Code: HWC
• UDI-Device Identifier: 00888867024168
• UDI-Public: 00888867024168
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2018

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: 07/01/2021
• Device Catalogue Number: AR-1934PS
• Device Lot Number: 10058034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/02/2018
• Supplement Date Received by Manufacturer: 01/02/2018
• Initial Report FDA Received Date: 01/19/2018
• Supplement Report FDA Received Date: 02/22/2018
• 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