MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SYSTEM 7 SAGITTAL SAW; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number 7208000000

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events one (1) event was reported for this quarter.Product return status one (1) device investigation type has not yet been determined.Additional information one (1) device was not labeled for single-use.One (1) device was not reprocessed or reused.

Event Description

This report summarizes one (1) malfunction event in which the device was reportedly leaking.One (1) event had no patient involvement.No patient impact.

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: h10 1 previously reported event is included in this follow-up record.Product return status 1 device was received.

Event Description

This report summarizes 1 malfunction event in which the device was reportedly leaking.- 1 event had no patient involvement; no patient impact.

• Brand Name: SYSTEM 7 SAGITTAL SAW
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 11729065
• MDR Text Key: 248762155
• Report Number: 3015967359-2021-00683
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07613252251033
• UDI-Public: 07613252251033
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 7208000000
• Device Catalogue Number: 7208000000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1