MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC HAND SWITCH FOR AIR PEN DRIVE; MOTOR, DRILL, PNEUMATIC

Catalog Number	05.001.082
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The actual device was returned for evaluation.The device was evaluated and there was no failure identified.Therefore, the reported condition was not confirmed and assignable root cause was not determined.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Event or Problem Description
It was reported from (b)(6) that during an unspecified surgical procedure, it was discovered that the hand switch device became locked.It was not reported if there were any delays in the surgical procedure or if a spare device was available.There was patient involvement reported.There were no reports of injuries, 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.

• Brand Name: HAND SWITCH FOR AIR PEN DRIVE
• Common Device Name: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7364992
• Report Number: 8030965-2018-52331
• Device Sequence Number: 2156769
• Product Code: HBB
• UDI-Device Identifier: 07611819831513
• UDI-Public: (01)07611819831513(11)090910
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K093361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/23/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 05.001.082
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Initial Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 03/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1