MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC SAW BLADE 12MM/25MM/5MM SHORTENING 45; BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL

Catalog Number	532.095S
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.
Event or Problem Description
This is report 1 of 2 for the same event.It was reported that during an ulnar osteotomy surgical procedure, it was observed that the saw blade device would not fit on the attachment and the wire device broke into two pieces (both devices were being used together during the same procedure.It was reported that there was a 10 minute delay in surgery in order to obtain a saw blade that would fit in the attachment.It was reported that both pieces of the wire were easily removed.It was reported that the procedure was completed with no further issues.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: SAW BLADE 12MM/25MM/5MM SHORTENING 45
• Common Device Name: BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7142285
• Report Number: 8030965-2017-50915
• Device Sequence Number: 1109562
• Product Code: GFA
• UDI-Device Identifier: 10886982241160
• UDI-Public: (01)10886982241160(11)160427(10)9926678
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/30/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 532.095S
• Device Lot Number: 9926678
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 12/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1