MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 2.5MM FLUTED DRILL W/ DEPTH STOP; BIT, DRILL

Catalog Number 72202890

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/15/2015

Event Type  malfunction  

Manufacturer Narrative

Product and lot numbers not provided.Initial reporter: zip: (b)(6).Phone: (b)(6).(b)(4).

Event Description

During a bankart repair operation it was reported that the drill broke.It occurred when the surgeon drilled the glenoid on 5 o'clock point.It was autoclaved before use.An inline drill guide was used.This device has been used at the facility from (b)(6) of 2011.The broken tip remained inside the site.An x-ray photo is not available.The operation was completed with a back-up anchor, using another site.

Manufacturer Narrative

Device evaluation: one 2.5mm fluted drill w/ depth stop was returned for evaluation.Visual assessment of the drill confirmed the reported breakage.The distal tip has broken from the shaft.Broken portion was not returned.The shaft is bent and is also scored is several places along its length.There is damage to the chucking area of the drill consistent with slippage within the drill chuck during use.Dimensional and material assessment of the drill confirmed it met print specifications.Per the device ifu under precautions ¿as with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure¿.A review of the device history records was performed which confirmed no inconsistencies.A complaint history review has not identified additional complaints for this lot number on file.Due to these observations no root cause related to the manufacturing process can be established.No further investigation is warranted at this time.(b)(4).

• Brand Name: 2.5MM FLUTED DRILL W/ DEPTH STOP
• Type of Device: BIT, DRILL
• 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: 5148620
• MDR Text Key: 28640400
• Report Number: 1219602-2015-01067
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72202890
• Device Lot Number: 50362566
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2016
• 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