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

Catalog Number 72202971

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during an acl reconstruction the tip of the flexible drill broke in the patient.The broken piece was successfully removed with cutting pliers.A backup device was utilized to complete the procedure.No patient injury or complications were reported.

Manufacturer Narrative

Visual inspection shows the device is bent at the distal tip.The damage appears to be consistent with encounter with a pin, another device, or hard bone.After the evaluation the root cause for the reported issue can be attributed to user error.A review of the device history record was performed which confirmed no inconsistencies.No further investigation is warranted at this time.

• Brand Name: DRILL, FLEXIBLE, ENDOSCPC, CANN, 4.5MM
• 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 ; 7000 w william cannon dr.; austin, TX 78735 ; 5123585706
• MDR Report Key: 6118967
• MDR Text Key: 60876963
• Report Number: 1219602-2016-01273
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• 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: 50616863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2016
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 42 YR