MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAPE RETRIEVER W/ NR HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	FIBERTAPE RETRIEVER W/ NR HANDLE
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint was confirmed.The device met all material specifications as received.Broken fibertape retriever jaw was returned along with complaint device.The related condition is typically caused by using the device to grasp and manipulate tissue, or when applying excessive leveraging forces.
Event or Problem Description
It was reported that during a shoulder scope rotator cuff repair procedure, after the surgeon implanted the medial row anchors and was passing suture through the cuff, the rounded end of the ar-13974nr, fibertape grasper broke off into the subacromial space within the subacromial bursa and other soft tissues.The tip broke off as the surgeon was retrieving suture and pulling suture out of the cannula.X-rays were then ordered to try and locate the broken fragment.As the surgeon was waiting on x-ray technicians, the surgeon went on to complete the biceps tenodesis portion of the procedure.The rep stated that the broken tip was clearly visible on x-ray, but the surgeon was having a hard time physically locating the broken fragment.The rep stated first, a mini c-arm was used to confirm the broken piece was in fact still in the shoulder and to specifically locate for retrieval.After 10-15 minutes of unsuccessful attempts to retrieve via the scope portals the surgeon briefly tried to view with the scope, but was reluctant to do so with fluid on as he did not want the item to be flushed around to make it potentially harder to locate.At this time he made the decision to transition to an open rcr approach to broaden his working room and help with local visualization.The mini c-arm was swapped out for full size c-arm after about 45minutes.After approximately another hour of searching with another partner physician now scrubbed in and assisting they went back in with the scope to view and perform more sad to help localize the item.It took approximately another 30-45minutes before the item was located and removed.The rep confirmed the broken tip was ultimately retrieved while the partner physician was continuing to perform arthroscopic sad with both a shaver and a wand to remove tissue and locate the item.The broken piece was finally pushed into the field of view with the wand, and a grasper was then used to fully remove the broken piece.The rcr was completed via the open approach once the broken fragment was removed.The rep confirmed that the item was fully removed from the patient, and no fragments remained.The rep reported that there was approximately a two and half hour delay in the case due to trying to retrieve the broken fragment.

• Brand Name: FIBERTAPE RETRIEVER W/ NR HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8008767
• Report Number: 1220246-2018-00718
• Device Sequence Number: 13859295
• Product Code: LXH
• UDI-Device Identifier: 00888867015791
• UDI-Public: 00888867015791
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/26/2018

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 Model Number: FIBERTAPE RETRIEVER W/ NR HANDLE
• Device Catalogue Number: AR-13974NR
• Device Lot Number: 55594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 10/26/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other