MAUDE Adverse Event Report: SYNVASIVE TECHNOLOGY, INC. RECIP DOUBLE SIDED STRYKER 76X12.5X1.00/1.19MM; RECIPROCATING SAW BLADE STRYKER®

Model Number N/A

Device Problems Component Missing (2306); Device Or Device Fragments Location Unknown (2590); Connection Problem (2900); Mechanical Jam (2983)

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

Event Date 03/16/2016

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to the manufacturer at the time of this report.A follow up medwatch will be submitted once the device has been returned and the investigation is complete.

Event Description

It was reported that the surgeon was cutting for a "box" on a p.S knee.The saw blade was stuck in bone.The surgeon noticed that the blade would not lock into the stryker system 7.The reciprocating saw blade was removed with pliers and cut was finished with a new blade.Upon inspection of the blade, it was noticed that locking tabs were missing on saw blade.The surgeon took interoperative x-rays and could not locate in patient.

Manufacturer Narrative

The device history record review noted no spontaneous anomalies, request for deviations, non-conformances or other issues with the production of this device.The review of the manufacturing process and the engineering design noted no systemic issues with this device.The customers reported event was that the saw blade got stuck in the bone during use and the blade would not lock in the hand piece.After removing the saw blade from the hand piece using pliers, it was noted that the locking tabs were missing.Inspection at incoming confirms that the mounting tabs were missing.Historically, the most probable cause for this event is the saw blade binding during use.The usual cause for binding saw blades is moving the saw hand piece too quickly for the saw teeth to adequately cut the material.The reported event noted that the saw blade got stuck.Most likely the pushing and pulling on the hand piece to free the bound saw blade caused the locking tabs to tear away from the mounting hub.This would cause the saw blade to not reattach and lock.The galling and scratches noted on the saw blade at incoming inspection are probably due to the pushing and pulling as well as the use of the pliers to remove the blade.There are no recommended actions at this time; the severity and frequency do not warrant further actions.

• Brand Name: RECIP DOUBLE SIDED STRYKER 76X12.5X1.00/1.19MM
• Type of Device: RECIPROCATING SAW BLADE STRYKER®
• Manufacturer (Section D): SYNVASIVE TECHNOLOGY, INC.; 4925 robert j. mathews pkwy; el dorado hills CA 95762
• Manufacturer (Section G): SYNVASIVE TECHNOLOGY, INC.; 4925 robert j. mathews pkwy; el dorado hills CA 95762
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 5537664
• MDR Text Key: 41982930
• Report Number: 0002950261-2016-00004
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 12076119SRL
• Device Lot Number: 55114
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 91