MAUDE Adverse Event Report: STRYKER TRAUMA KIEL IM REAMER, AO FITTING BIXCUT Ø12,0X480 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 02258120

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Death (1802)

Event Date 10/19/2018

Event Type  Death  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Disposition is unknown.

Event Description

The surgeon was undertaking a t2 nailing procedure in a (b)(6) year old female patient.At the start of the case during reaming with bixcut reamers, the patient had a pulmonary embolism.The surgeons attempted resuscitation and transferred the patient to itu but the patient passed away some time later.There were no reports of any issues with the bixcut reamer during use and the t2 nail had not been implanted.Update: the patient was a (b)(6) female, overweight (high bmi).She attempted a half marathon on (b)(6) 2018 but dropped out.She complained to a&e of thigh pain, a stress fracture was later noted after 3 visits to hospital and was admitted for an im nail procedure.The case was progressing as planned without incident, however there was a spiral fracture which the surgeons face difficulty in reducing.Following reduction the surgeon started reaming using the bixcut reamers the anaesthetist reported a pe and the need to intubate and the surgeon stopped the procedure following this they started to stabilise the patient and perform cpr.After 15 mins the anaesthetist confirmed that she would not be fit for continuation with the nail even if she was stabilized.All of these devices has been in use at the time the event happened as that sequential reaming took place increasing diameter from 9mm ¿ 14.5mm.

• Brand Name: IM REAMER, AO FITTING BIXCUT Ø12,0X480 MM
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8075177
• MDR Text Key: 127338740
• Report Number: 0009610622-2018-01395
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 04546540145420
• UDI-Public: 04546540145420
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02258120
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2018
• 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): Death
• Patient Age: 33 YR