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

Model Number 72202971

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/02/2017

Event Type  malfunction  

Event Description

It was reported that the drill bit broke.All the pieces were removed from the patient.No patient injuries were reported.

Manufacturer Narrative

Examination was not possible, as the device has not been returned.The investigation could not draw any conclusions about the reported event without the return of the device.Review of manufacturing records found no non-conformance's or inconsistencies for this lot.

Manufacturer Narrative

One 4.5mm flexible endoscopic drill was returned for evaluation.Visual assessment of the drill confirmed the reported breakage.Drill has broken where double helix transitions to 9 revs per inch.No material voids are present at the break area.The drill is uncoiled at the break area and the drill head, which is consistent with operating the drill in reverse.The proximal end of the drill that interfaces shows evidence of the drill slipping in the drill chuck.

• 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 drive; austin, TX 78735
• MDR Report Key: 6875364
• MDR Text Key: 87377984
• Report Number: 1219602-2017-01157
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010654526
• UDI-Public: (01)03596010654526(10)50554567
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/28/2017

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 Model Number: 72202971
• Device Catalogue Number: 72202971
• Device Lot Number: 50554567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2017
• Initial Date FDA Received: 09/19/2017
• Supplement Dates Manufacturer Received: 10/24/2017; 12/27/2017
• Supplement Dates FDA Received: 10/25/2017; 12/28/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 20 YR