MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL, FLEXIBLE, ENDOSCPC, CANN, 4.5MM; ACCESSORIES,ARTHROSCOPIC

Model Number 72202971

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/02/2018

Event Type  malfunction  

Event Description

It was reported that during reaming of femur using the clancy system with the 4.5 reamer, the tip broke off but remained on the 2.4 mm guide wire where it was removed.Breakage occurred inside the patient but broken pieces were removed.A backup device was available to complete the procedure with no major delay or patient injuries.

Manufacturer Narrative

Examination was not possible, as the device has not been returned.The investigation could not draw any conclusions about the reported event without the return of the device.

• Brand Name: DRILL, FLEXIBLE, ENDOSCPC, CANN, 4.5MM
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• 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 ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7509674
• MDR Text Key: 108239577
• Report Number: 1219602-2018-00575
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010654526
• UDI-Public: (01)03596010654526(10)50616863
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72202971
• Device Catalogue Number: 72202971
• Device Lot Number: 50616863
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1