MAUDE Adverse Event Report: ARTHREX, INC. DISPOSABLE INSTRUMENT KIT FOR TENODESIS SCREW; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	AR-1676DS
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2017
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.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 will not be returned by the facility.Lot number is unknown so the device history record review cannot be performed.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.The potential cause(s) of this event will be communicated to the event report.If additional relevant information is received, a follow-up report will be submitted.Risk manager will not release device.
Event or Problem Description
It was reported that on (b)(6) 2017, during a proximal biceps tenodesis case, the surgeon was using a disposable instrument kit for tenodesis screw.After dissecting down to the point on the humerus where he wanted to place the repair he drilled an arthrex 2.4 guide pin into the site.The guide pin came from the disposable instrument kit for tenodesis screw (ar-1676ds).After drilling the guide pin, he then over-reamed with an 8.5mm reamer from an arthrex bio-tenodesis set.After reaming to the desired depth, pulling the drill out, and dismantling the drill from power, the surgeon noticed that the guide pin was missing.He immediately picked up the reamer and looked through the cannulation to discover that the drill pin was still stuck inside the reamer.He then placed the reamer with the pin stuck inside of it back down on the mayo stand.The surgeon was able to create the socket and subsequently screw in an 8mm forked tip sl teno anchor successfully securing the tendon and completing the tenodesis.After the surgery, it was discovered that a piece of the guide pin broke-off and was retained inside of the patient.The surgeon was able to successfully remove the retained portion in a subsequent surgery five days later on (b)(6) 2017.

• Brand Name: DISPOSABLE INSTRUMENT KIT FOR TENODESIS SCREW
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6571650
• Report Number: 1220246-2017-00171
• Device Sequence Number: 91125
• Product Code: GAT
• UDI-Device Identifier: 00888867020801
• UDI-Public: 00888867020801
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K041553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 05/17/2017

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-1676DS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2017
• Initial Report FDA Received Date: 05/17/2017
• 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