MAUDE Adverse Event Report: N/I RADIOLUCENT DRIVE MARK II; MOTOR, DRILL, PNEUMATIC

Catalog Number 511.30

Device Problem Device Slipped (1584)

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

Event Type  malfunction  

Event Description

It was reported from (b)(6) that during an unspecified surgical procedure, it was discovered that the radiolucent drive mark device ¿slipped¿.There was a two minute delay in the surgical procedure.A spare device was available for use.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

(b)(6).The manufacture facility was unknown.The date of manufacture was unknown.The actual device was returned for evaluation.Reliability engineering evaluated the device.A functional assessment was performed and the device passed all operational specifications.The reported condition was not confirmed.Therefore, an assignable root cause was not determined.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.

• Brand Name: RADIOLUCENT DRIVE MARK II
• Type of Device: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): N/I; n/i; n/i
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3818220
• MDR Text Key: 4503133
• Report Number: 2520274-2014-11190
• Device Sequence Number: 1
• Product Code: HBB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK971544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 511.30
• Device Lot Number: 4218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2014
• Date Manufacturer Received: 03/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1