MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GUIDE,2.3MM INLINE DRILL, SPIKE TIP; ACCESSORIES,ARTHROSCOPIC

Catalog Number 72201110

Device Problems Difficult to Remove (1528); Component Missing (2306); Mechanical Jam (2983)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/17/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

During a shoulder stabilization procedure it was reported that following drilling with the crown tip drill guide, it was noticed that one of the spikes of the crown was missing and had got stuck in the bone.The surgeon was unable to retrieve it, but otherwise completed the procedure successfully.

Manufacturer Narrative

The device has a thin wall at the tip geometry and when excessive force is placed on the device it can break.No harm or injury to the patient has been reported and the surgeon has not advised of future plans to remove the retained tip fragment.Shaft material is (b)(4), testing performed on material has not been determined it to be toxic if implanted.

• Brand Name: GUIDE,2.3MM INLINE DRILL, SPIKE TIP
• 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: james gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5289529
• MDR Text Key: 33862268
• Report Number: 1219602-2015-01247
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 11/17/2015

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: 72201110
• Device Lot Number: 50283984
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/17/2015
• Initial Date FDA Received: 12/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2009
• 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