MAUDE Adverse Event Report: ARTHREX INC. 5.5MM BIO-COMP. CORKSCREW FT W/ SUTURETAPE; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	AR-1927BCT
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2018
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.Lot number was not provided so device history record review cannot be performed.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.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 originally reported that the suture anchor broke on insertion.No further details.Available at time of initial report.Follow-up investigation: it was reported that during an open rotator cuff repair procedure, the bio-composite corkscrew cracked and broke on insertion.Most of the anchor was retrieved, but the rep is not sure if the entire anchor was pulled out after it cracked and broke.A different anchor (ar-1928sf-3) was used to complete the repair.Originally, the surgeon had the resident punch and insert ar-1927bct.Upon punching, the rep noticed the resident was having difficulty getting the punch in the bone, and it sounded as if the bone was very hard.The rep recommended the surgeon and/or resident use the tap associated with ar-1927bct, as it was readily available in a tray in the room.However, the surgeon did not want to open the tray, and decided against using the tap the rep recommended.Once the decision was made by the surgeon to not use the tap, the rep reminded the surgeon and resident the anchor must be inserted at the same angle at which the punch was used.Following the surgeon's instruction, the resident inserted ar-1927bct after punching (without using a tap) and the anchor broke.
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.This is a follow-up submission for additional information received.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 showed nothing relevant to the 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.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 originally reported that the suture anchor broke on insertion.No further details.Available at time of initial report.Follow-up investigation: it was reported that during an open rotator cuff repair procedure, the bio-composite corkscrew cracked and broke on insertion.Most of the anchor was retrieved, but the rep is not sure if the entire anchor was pulled out after it cracked and broke.A different anchor (ar-1928sf-3) was used to complete the repair.Originally, the surgeon had the resident punch and insert ar-1927bct.Upon punching, the rep noticed the resident was having difficulty getting the punch in the bone, and it sounded as if the bone was very hard.The rep recommended the surgeon and/or resident use the tap associated with ar-1927bct, as it was readily available in a tray in the room.However, the surgeon did not want to open the tray, and decided against using the tap the rep recommended.Once the decision was made by the surgeon to not use the tap, the rep reminded the surgeon and resident the anchor must be inserted at the same angle at which the punch was used.Following the surgeon's instruction, the resident inserted ar-1927bct after punching (without using a tap) and the anchor broke.

• Brand Name: 5.5MM BIO-COMP. CORKSCREW FT W/ SUTURETAPE
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7341115
• Report Number: 1220246-2018-00086
• Device Sequence Number: 16649915
• Product Code: MAI
• UDI-Device Identifier: 00888867251267
• UDI-Public: 00888867251267
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K082810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2018

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: 06/01/2019
• Device Catalogue Number: AR-1927BCT
• Device Lot Number: 10148799
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/19/2018
• Supplement Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 03/15/2018
• Supplement Report FDA Received Date: 06/19/2018
• 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