MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC RECIP SAW BLADE DBL-SIDED 68MM X 1.10MM; BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL

Catalog Number	511.912S
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual device has been returned and is currently pending evaluation.Once the evaluation of the device has been completed, a supplemental medwatch report will be sent accordingly.
Event or Problem Description
It was reported from (b)(6) that during a total knee arthroplasty (tka) surgical procedure for knee osteoarthritis it was observed that the tip of the saw blade device broke.It was reported that there was no delay in the procedure due to the event.It was not reported if there was a spare device available for use.There was patient involvement reported.It was reported that nothing wrong was found with x-ray imaging, but a possibility of broken parts being left in the body could not be denied.The exact date of the event was not reported.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that at the top of the saw blade a tooth was broken off.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 report will be submitted accordingly.

• Brand Name: RECIP SAW BLADE DBL-SIDED 68MM X 1.10MM
• 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: 7123557
• Report Number: 8030965-2017-50762
• Device Sequence Number: 1798522
• Product Code: GFA
• UDI-Device Identifier: 10886982238207
• UDI-Public: (01)10886982238207(11)170421
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 511.912S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Initial Date Received by Manufacturer: 11/24/2017
• Supplement Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 12/15/2017
• Supplement Report FDA Received Date: 02/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention