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

Catalog Number 72202971

Device Problem Computer Operating System Problem (2898)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that when passing the drill through the flexible wire, it broke through the bone before breaking the cortex.

Manufacturer Narrative

Examination was not possible, as the device was not returned.The investigation was limited to the information provided.The investigation could not draw any conclusions about the reported event with the clinical details provided.A review of the device history record was performed which confirmed no inconsistencies.No further investigation is warranted at this time.

Manufacturer Narrative

One 4.5 flexible endoscopic cannulated drill bit was returned for evaluation.Visual assessment of the drill confirmed the reported complaint of breakage.The drill shaft has broken where it transitions from the 20 ½ to 9 revolutions per inch at the lazer cut double helix.No material voids are present at the break area.Broken distal portion of the drill was not returned for examination making a root cause prohibitive.Further investigation is not warranted at this time.

• 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 w. william cannon; austin, TX 78735 ; 5123585706
• MDR Report Key: 6190340
• MDR Text Key: 63231804
• Report Number: 1219602-2016-01390
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72202971
• Device Lot Number: 50554567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/24/2016
• Initial Date FDA Received: 12/20/2016
• Supplement Dates Manufacturer Received: Not provided; 04/30/2018
• Supplement Dates FDA Received: 02/22/2017; 05/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1