MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN STRYKER INSTRUMENT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number UNK_JR

Device Problem Insufficient Information (3190)

Patient Problem Cardiac Arrest (1762)

Event Date 05/05/2022

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

This pi is for the intra-operative cardiac arrest.As reported by complaint form: "before case start when the scrub was loading the saw blade, the strait attachment would not stay locked closed, keep popping up.The case did cancel but only because pt coded on the table, not because of the mako system/instruments.Case type / application: rtka" spoke to mps.The following sequence of events occurred: prior to the patient being in the operating room, the saw attachment would not lock the blade.A second attachment was able to lock the blade.Patient was brought to the operating room and placed under anesthesia.The knee was opened and registered for a mako tka (placement of arrays and checkpoints).Surgeon preference is to manually prepare the patella prior to making any robotic cuts, had resected half the patient's patella when the patient began going into cardiac arrest.Possible cause or contributor for cardiac arrest not reported to the mps.The mps moved the robot out of the way.Checkpoints and arrays were removed, patient closed, atropine administered, and a nurse performed chest compressions as the anesthesiologist brought in a crash cart.When the mps left the operating room, the patient was in stable condition and was being prepared to be transferred to the icu.Mps will advise of any updates to patient status.Otherwise, no further information will be released by the hospital or surgeon.

• Brand Name: UNKNOWN STRYKER INSTRUMENT
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 14519953
• MDR Text Key: 292971950
• Report Number: 0002249697-2022-00772
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization
• Patient Sex: Male