MAUDE Adverse Event Report: ARTHREX, INC. HEADED REAMER 8 MM, CANNULATED; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	HEADED REAMER 8MM, CANNULATED
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/08/2019
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 during an anterior cruciate ligament (acl) procedure that an ar-1407 (7mm cannulated headed reamer) was used.It was indicated that material broke off from the instrument and remains in the patient.The surgery was finished with a new device with a different part number, ar-1408.It was not necessary to switch the surgical technique or do a second surgery.Update (b)(6) 18-apr-2019: additional information has been received that part ar-1887-08p (transfix tunnel hook 7) was also involved in this incident.This device is not approved for sale in the usa.Update (b)(6) 29-apr-2019: the head of the device ar-1887-08p, which actually should pull the wire out, did not come out, hence it broke off.It was a device which has been used very rare and which has been controlled routinely.Since this incident sensitive controls have been initiated.A dropping or any other misuse of the affected device cannot be detected.The loop of this device remained inside the patient.It was noted that it can only been removed with high technical effort and that leaving it remaining inside the patient can be expected to have no further consequences.Hence the part has remained inside the patient.After over drilling the device the fragment has canted itself and a movement is not expected.Shaving in a minimum of shape of the milling cannot be excluded, however visible shavings do not exist.Update 07-may-19: surgeon confirmed that part number ar-1887-08p originally reported was incorrect.Surgeon has confirmed that part ar-1887-07p was used and is the correct part number.The surgeon could not confirm if any portion of the ar-1407 came off or remained in the patient.When the device is received a full evaluation will be conducted to determine if anything came off the device and could be remaining in the patient.If needed, the information will be updated accordingly at that time.
Additional Manufacturer Narrative
Complaint not confirmed, the device returned was found to be whole with minor wear damage at the distal end.
Event or Problem Description
It was reported that during an anterior cruciate ligament (acl) procedure that an ar-1407 (7mm cannulated headed reamer) was used.It was indicated that material broke off from the instrument and remains in the patient.The surgery was finished with a new device with a different part number, ar-1408.It was not necessary to switch the surgical technique or do a second surgery.Update 18-apr-2019: additional information has been received that part ar-1887-08p (transfix tunnel hook 7) was also involved in this incident.This device is not approved for sale in the usa.Update 29-apr-2019: the head of the device ar-1887-08p, which actually should pull the wire out, did not come out, hence it broke off.It was a device which has been used very rare and which has been controlled routinely.Since this incident sensitive controls have been initiated.A dropping or any other misuse of the affected device cannot be detected.The loop of this device remained inside the patient.It was noted that it can only been removed with high technical effort and that leaving it remaining inside the patient can be expected to have no further consequences.Hence the part has remained inside the patient.After over drilling the device the fragment has canted itself and a movement is not expected.Shaving in a minimum of shape of the milling cannot be excluded, however visible shavings do not exist.Update 07-may-19: surgeon confirmed that part number ar-1887-08p originally reported was incorrect.Surgeon has confirmed that part ar-1887-07p was used and is the correct part number.The surgeon could not confirm if any portion of the ar-1407 came off or remained in the patient.When the device is received a full evaluation will be conducted to determine if anything came off the device and could be remaining in the patient.If needed, the information will be updated accordingly at that time.Update 05-june-19 instead of the device ar-1407 the device ar-1408 was used.Also we received the device ar-1408 for evaluation.

• Brand Name: HEADED REAMER 8 MM, CANNULATED
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8591600
• Report Number: 1220246-2019-01083
• Device Sequence Number: 2169565
• Product Code: LXH
• UDI-Device Identifier: 00888867016668
• UDI-Public: 00888867016668
• 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): 06/12/2019

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 Model Number: HEADED REAMER 8MM, CANNULATED
• Device Catalogue Number: AR-1408
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Initial Date Received by Manufacturer: 04/12/2019
• Supplement Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 06/12/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other