MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL, FLEXIBLE, ENDOSCOPIC, CANNLD, 6MM

Model Number 72202594

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

Device will not be returned for evaluation, therefore, no conclusion can be made.(b)(4).

Event Description

In a reported case study using a drill, flexible, endoscopic, cannulated, 6mm, the authors created the tibial tunnel after creating the femoral tunnel, which is the opposite of how the procedure is described in the smith & nephew technical guide for this product, authored by (b)(6).Also, the authors had to flex the knee to 130 degrees to attain the critical 45-degree superolateral trajectory because a remnant tibial stump prevented the drill guide from resting on the lateral femoral condyle.A 6-mm flexible reamer was brought to the knee along the guide pin, but when the lateral femoral condyle was reamed to approximately 20 mm, the reamer broke at about 60 mm from its tip.The authors report that no excessive force or counterclockwise rotation was involved.The broken reamer was removed with a kelly clamp.Drilling was completed with larger-diameter flexible femoral reamer and the procedure was finished.A postoperative radiography showed posterior-wall blowout of the femoral cortex.

Manufacturer Narrative

Device will not be returned for evaluation, therefore no conclusion can be made.Since there is no lot/batch information, manufacturing review is not possible.Root cause undetermined after investigation.(b)(4).

• Brand Name: DRILL, FLEXIBLE, ENDOSCOPIC, CANNLD, 6MM
• Type of Device: DRILL, FLEXIBLE, ENDOSCOPIC, CANNLD, 6MM
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5224311
• MDR Text Key: 31195204
• Report Number: 1219602-2015-01169
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 72202594
• Device Catalogue Number: 72202594
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20 YR