MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDOBUTTON CL ULTRA PAC, 1.2

Model Number 72202799

Device Problems Break (1069); Failure to Align (2522); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/25/2014

Event Type  malfunction  

Event Description

During an anterior cruciate ligament (acl) reconstruction procedure utilizing an endobutton cl ultra pac, 1.2, it was reported that the drill bit broke inside the patient.The surgeon could not locate the broken piece and it may be in the patient¿s bone.The guide pin was noticeably kinked.The surgeon hyper-flexed the knee because axial alignment was lost.There was a reported 10 minutes procedural delay.A backup device was available to complete the procedure.The patient¿s bone quality was average.There were no reported patient injuries or complications.

Manufacturer Narrative

Investigation results: only the 4.5mm endobutton drill was returned from the endobutton cl ultra pac for evaluation.Visual examination of the drill confirmed the reported complaint of the drill head breaking off.Drill head was not returned for evaluation.Examination of the break confirmed that the device was deformed; indicative of attempting to drill over a bent guidewire/passing pin.As reported, the guide pin was noticeably kinked during hyper flexion of the knee.Due to the condition of the returned device and the information provided, we have determined that the device failure is the result of customer induced damage by attempting to drill over a bent guidewire.A review of the device history records and quality records associated with this manufactured lot confirmed that no abnormalities were reported with this product lot during manufacture.No further investigation is required at this time.(b)(4).

• Brand Name: ENDOBUTTON CL ULTRA PAC, 1.2
• Type of Device: ENDOBUTTON CL ULTRA PAC, 1.2
• 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: brenda driscoll ; 150 minuteman road; andover, MA 01810 ; 9787491462
• MDR Report Key: 4177875
• MDR Text Key: 5100640
• Report Number: 1219602-2014-00297
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: 72202799
• Device Catalogue Number: 72202799
• Device Lot Number: 50506734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1