MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS 2.3MM FLUTED MATCHSTICK; MOTOR, DRILL, ELECTRIC - CUTTING BURR

Catalog Number L-8N

Device Problems Product Quality Problem (1506); Device Contamination with Chemical or Other Material (2944); Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 04/08/2016

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: (b)(6).Device manufacture date: the device manufacture date is unavailable.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the match stick burr device looked dirty when they took it out from the sterile package.It was reported that the dirty device was placed in water and the water also became dirty.It was reported that the sterile package was not damaged.It was reported that there was a five minute delay in the procedure.It was not reported if a spare device was available for use.There was patient involvement reported.There were no patient or user injuries reported.It was reported there was no medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

The event date ((b)(6) 2016) was inadvertently entered into the initial medwatch.Upon further investigation it was found that the actual event date is unknown.The incorrect lot number (j263107395) was inadvertently entered into the initial medwatch report.The actual lot number is unknown and has been captured as n/i.(b)(6).If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

The lot number was inadvertently omitted in the previous report.It has been updated as j263107395.Device evaluation: the actual device was returned for evaluation.Reliability engineering evaluated the device and identified no failure.Therefore, the reported condition was not confirmed.An assignable root cause was not determined.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

The previous report stated the date of manufacture (dom) was unknown.The dom has been updated to reflect the date (aug 5, 2015) the device was manufactured.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: 2.3MM FLUTED MATCHSTICK
• Type of Device: MOTOR, DRILL, ELECTRIC - CUTTING BURR
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: rodney crain ; 4500 riverside drive; palm beach gardens, FL 33410 ; 5616271080
• MDR Report Key: 5594624
• MDR Text Key: 44165980
• Report Number: 1045834-2016-11519
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK011444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: L-8N
• Device Lot Number: J263107395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1