MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC SAW BLADE, 90MM X 9.5-19MM, 1.27MM CUT; BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL

Catalog Number	05.003.126S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter¿s complete mailing address was not provided.Reporter¿s phone number was not provided.Reporter¿s contact name was not provided.The manufacturing location is unknown.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
It was reported from (b)(6) that during a total knee arthroplasty surgical procedure, it was observed that the saw blade was broken.It was not reported if there were any delays in the surgical procedure or whether a spare device was available for use.It was reported that there were no broken parts in the patient's body.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.
Additional Manufacturer Narrative
The actual device was returned for evaluation.Reliability engineering evaluated the device and determined that the saw blade was broken off into two parts.It was also determined that the device appeared to have been struck with a very hard metallic object and may have come into contact with a metallic guide.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to improper handling, which is user error/misuse/abuse.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: SAW BLADE, 90MM X 9.5-19MM, 1.27MM CUT
• 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: 7508614
• Report Number: 8030965-2018-53688
• Device Sequence Number: 1529758
• Product Code: GFA
• UDI-Device Identifier: 10886982131287
• UDI-Public: (01)10886982131287(11)161216
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 04/17/2018

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: 05.003.126S
• Device Lot Number: H240922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Initial Date Received by Manufacturer: 04/17/2018
• Supplement Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 05/11/2018
• Supplement Report FDA Received Date: 06/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1