MAUDE Adverse Event Report: ARTHREX INC. IMPLANT SYSTEM, CMC LIGAMENT RECONSTRUCTION; SCREW, FIXATION, BONE

Model Number	AR-1677BC-CP
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/20/2017
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.The device was requested for evaluation but was not returned 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.If additional relevant information is received, a follow-up report will be submitted.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.
Event or Problem Description
It was reported that during a cmc ligament reconstruction case, after the surgeon cut the fcr tendon and placed the new tendon through the incision made at the dorsoradial aspect of the wrist, he drilled with the guide pin into the 1st metacarpal.He then continued with the cannulated drill.He used the quickpass tendon shuttle and was successful in passing the tendon through the newly created tunnel.The 4 mm x 10 mm tenodesis screw, that's included in the cmc implant system was then placed on the driver and he attempted to place the screw and tendon into the hole.He attempted to advance the screw into the hole, but was unsuccessful in his first attempt.He retried and was still unable to advance the screw.He then noticed the screw had broken; the threading on the screw came apart, and the front half of the screw had broken-off and was left in the patient.However, the tendon and screw were not flush.The remainder of the screw was still attached to the driver and you could visibly see the threading of the screw and where it had broken.A new kit was opened up to complete the procedure.The remains of the first tenodesis screw were unable to be removed during the procedure.Patient is a (b)(6) female.
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 due to device evaluation.Complaint confirmed.The evaluation revealed that the screw's threads have peeled from distal to proximal end.This type of event is typically caused by not inserting the implant co-axial to the bone tunnel, causing the implant to hit the edge of the prepared hole.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.
Event or Problem Description
It was reported that during a cmc ligament reconstruction case, after the surgeon cut the fcr tendon and placed the new tendon through the incision made at the dorsoradial aspect of the wrist, he drilled with the guide pin into the 1st metacarpal.He then continued with the cannulated drill.He used the quickpass tendon shuttle and was successful in passing the tendon through the newly created tunnel.The 4mmx10mm tenodesis screw, that's included in the cmc implant system was then placed on the driver and he attempted to place the screw and tendon into the hole.He attempted to advance the screw into the hole, but was unsuccessful in his first attempt.He retried and was still unable to advance the screw.He then noticed the screw had broken; the threading on the screw came apart, and the front half of the screw had broken-off and was left in the patient.However, the tendon and screw were not flush.The remainder of the screw was still attached to the driver and you could visibly see the threading of the screw and where it had broken.A new kit was opened up to complete the procedure.The remains of the first tenodesis screw were unable to be removed during the procedure.Patient is a (b)(6) female.

• Brand Name: IMPLANT SYSTEM, CMC LIGAMENT RECONSTRUCTION
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6934410
• Report Number: 1220246-2017-00371
• Device Sequence Number: 1239523
• Product Code: HWC
• UDI-Device Identifier: 00888867096066
• UDI-Public: 00888867096066
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K051726
• 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): 11/08/2017

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: 11/01/2018
• Device Model Number: AR-1677BC-CP
• Device Catalogue Number: AR-1677BC-CP
• Device Lot Number: 10080493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/21/2017
• Supplement Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 10/10/2017
• Supplement Report FDA Received Date: 11/08/2017
• 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: 61 YR