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

Catalog Number 7208000000

Device Problem Imprecision (1307)

Patient Problem Tissue Damage (2104)

Event Date 10/23/2017

Event Type  Injury  

Event Description

It was reported that during a total knee repair the user alleged that the device was 'whipping' and came loose from the device.This resulted in the acl to be damaged during the procedure.As a result of this the patient required a hamstring graft.Attempts were made to obtain additional information about the event; no further information was received at this time.

Manufacturer Narrative

Supplemental submitted to document device evaluation results.

Event Description

It was reported that during a total knee repair the user alleged that the device was 'whipping' and came loose from the device.This resulted in the acl to be damaged during the procedure.As a result of this the patient required a hamstring graft.Attempts were made to obtain additional information about the event; no further information was received.

• Brand Name: SYSTEM 7 SAGITTAL SAW
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: zachary baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 7048858
• MDR Text Key: 92631747
• Report Number: 0001811755-2017-02368
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7208000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other