MAUDE Adverse Event Report: ARTHREX, INC. REAMER, LOW PROFILE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	REAMER, LOW PROFILE
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that a bone tendon bone surgery was performed.During the femoral drilling over the drill pin, the tip of the low profile drill has broken off.The drill pin was then slightly bent.The surgeon wanted to retrieve the broken fragment of the drill from the knee, but could not find it.The patient was x-rayed during the surgery to find the broken fragment, but the surgeon could not locate it on the image converter.The broken part remains in the patient's knee.According to the surgeon, he does not want to perform a second surgery.Overall, it was a very difficult surgery.The surgery was completed successfully with arthrex device ar-1409.
Additional Manufacturer Narrative
Complaint confirmed, the reamer head broke off from the device.The most likely cause of the event is hitting the guide pin during use.

• Brand Name: REAMER, LOW PROFILE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9353297
• Report Number: 1220246-2019-01426
• Device Sequence Number: 469813
• Product Code: LXH
• UDI-Device Identifier: 00888867016767
• UDI-Public: 00888867016767
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2019

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: 02/28/2021
• Device Model Number: REAMER, LOW PROFILE
• Device Catalogue Number: AR-1409LP
• Device Lot Number: 10032056
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/01/2019
• Supplement Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 12/13/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other