MAUDE Adverse Event Report: STRYKER TRAUMA KIEL IM REAMER, AO FITTING BIXCUT Ø11,5X480 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	02258115
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Death (1802)
Date of Event	10/19/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Disposition is unknown.
Event or Problem Description
The surgeon was undertaking a t2 nailing procedure in a (b)(6) 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 a 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 Ø11,5X480 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8075100
• Report Number: 0009610622-2018-01390
• Device Sequence Number: 13503800
• Product Code: LXH
• UDI-Device Identifier: 04546540145413
• UDI-Public: 04546540145413
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 02258115
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 11/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 33 YR