MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. OSCILLATING SAW BLADE STRYKER® SYSTEM 6; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number N/A

Device Problems Fracture (1260); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The investigation is still in progress.Once the investigation is complete a follow up mdr will be submitted.

Event Description

It was reported that the pin fell out causing the screw to be loose.Saw blade was broken.No surgical delay happen.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The device history record (dhr) for the oscillating saw blade strykerâ® system 6, part number 562710601, review could not be performed as a lot number was not provided for the reported event.On (b)(6) 2019, it was reported from (b)(6) that an oscillating saw blade strykerâ® system 6 had the pin fall out causing the screw to be loose.The saw blade was broken.A returned product investigation could not be performed for the reported event due to the product not being returned for evaluation.The reported event can, therefore, not be confirmed.The root cause of the reported event cannot be specifically determined with the provided information because the product was not returned for evaluation.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

No additional event information.

• Brand Name: OSCILLATING SAW BLADE STRYKER® SYSTEM 6
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8634232
• MDR Text Key: 145938674
• Report Number: 0001526350-2019-00390
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• 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: 562710601
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1