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

Catalog Number 506121

Device Problems Break (1069); Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2020

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under cmp-(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 saw blade was broke while using at the point of blade that inserts into the saw and did not result in any harm.Event occurred during surgery.There was a patient involved however there was no harm and no delay.

Event Description

No additional event information.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Udi #: (b)(4).Concomitant therapy: item#: 25090137, item name: oscillating saw blade, lot#: 341940 the dhr review did not note of any non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing related to the reported event.The dhr review found all verifications, inspections, and tests to be successfully completed.On 21 feb 2020, a returned product investigation was performed on the oscillating saw blade strykerâ® system 6.The physical evaluation revealed that the returned blade had a broken hub, damaged teeth and deformation on the edge of the blade.The results of the returned product investigation have confirmed the reported event.While the returned product investigation confirmed that the oscillating saw blade strykerâ® system 6 was broke at the hub, it cannot be determined from the information provided what actually caused the reported event.Therefore, based on the information provided, a specific root cause of the reported event cannot be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

• 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: 9662605
• MDR Text Key: 195279987
• Report Number: 0001526350-2020-00109
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 506121
• Device Lot Number: 262761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1