MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDOSCPC CANN.DRL.BIT 4.5 STRL; BIT, DRILL

Catalog Number 7207315

Device Problems Break (1069); Component Falling (1105)

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

Event Date 04/05/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Subject device was returned for evaluation.Visual assessment confirmed the complaint failure mode of ¿broken drill¿.The entire drill head has broken free from the shaft.The drill shaft is slightly bent.Drill head was not returned for evaluation.A review of the device history report(s) did not identify any discrepancies.A review of the complaint history confirmed that no additional complaints were associated with the manufactured lot on file.Due to the condition of the returned device, a root cause be determined with confidence.There are no indications that would suggest that the device did not meet product specifications upon release into distribution.

Event Description

During an anterior cruciate ligament repair (acl) procedure utilizing the endoscopic cannulated drill bit-4.5mm, it was reported that the tip of the drill bit broke off during surgery.The surgeon was able to successfully remove the fragment from the knee joint.Backup device was on hand and the surgeon was able to complete the procedure successfully.(b)(4).

• Brand Name: ENDOSCPC CANN.DRL.BIT 4.5 STRL
• 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: jim gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5942981
• MDR Text Key: 54804466
• Report Number: 1219602-2016-00587
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 7207315
• Device Lot Number: 50441468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1