MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	3289002
Medical Device Problem Codes	Disassembly (1168); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Laceration(s) (1946); Blood Loss (2597)
Date of Event	02/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) (cross threaded).Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.However product images were submitted but due to image lighting and quality, in addition to blood and biological material on both instruments, it disallow additional information from being gleaned from the pictures.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that on: (b)(6) 2016: patient presented with internal disruption of l5/s1 disk with intractable pain back and bilateral legs respectively, status post discographic workup.Patient underwent the following procedure: anterior lumbar interbody fusion at l5-s1 with radical discectomy using graft supercharged with rhbmp-2/acs with fluoroscopic supervision during same, and left intra abdominal iliac vein repair.Per-op notes: ¿.I proceeded to graft the l5-s1 space with rgraft as a carrier supercharged with rhbmp-2/acs.¿ intra-operatively,the handle, which was used to place the template, dislodged from the template and hit the patient's iliac vein, resulting in a laceration of the iliac vein.The handle was used to place the template in the disc place, as a measuring device, prior to the insertion of the permanent cage.Allegedly, "as a result of the laceration to the iliac vein, the patient lost 4650 cc of blood before the neurosurgeon and a vascular surgeon in the operative suite were able to repair the iliac vein and stop the bleeding.Because of this event, the cage lumbar fusion was abandoned." reportedly, "following the laceration of the iliac vein, a valiant attempt was made to save the patient's life.A large volume of crystalloids, platelets, fresh frozen plasma (ffp), and other fluids were given to the patient.Once patient was stabilized, patient was transferred to the intensive care unit for follow-up care." allegedly, " an inspection of the template by the surgical technician in the operative suite noted cross-threading between the template and the handle that led to assembly failure between the template and the handle." on (b)(6) 2016: patient presented with left thigh and left calf compartment syndrome.On (b)(6) 2016: patient presented with left medial compartment(adductor) thigh compartment syndrome evolution with malfunctioning wound vac.Patient underwent left medial adductor thigh fasciotomy.Inspection and re-application of 2 wound vacs to the thigh and left(calf) wounds respectively.On (b)(6) 2016: patient presented with swelling on left foot.On (b)(6) 2016: patient presented for wound check.On (b)(6) 2016: patient presented with left thigh lateral wound bed and left medial and left calf wound bed, status post fasciotomies.On (b)(6) 2016: patient presented in the office for repeat wound culture.On (b)(6) 2016: patient presented for two week wound check.On (b)(6) 2016: patient presented for wound check and post-op check.On (b)(6) 2016: patient presented with increased lumbar pain with x rays.On examination patient had sacral tenderness.Patient had cervicalgia, gerd and tenderness over the cervical thoracic junction.On (b)(6) 2016: patient underwent x-rays.On (b)(6) 2016: patient presented for a follow-up.Patient is reported ambulating without evidence of gait.On (b)(6) 2016: patient presented with pain.On (b)(6) 2016: patient presented with preoperative diagnosis of query left sacroiliitis and underwent left sacroiliac joint arthrogram with fluoroscopic guidance.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 6408505
• Report Number: 1030489-2017-00550
• Device Sequence Number: 13682758
• Product Code: LXH
• UDI-Device Identifier: 00885074035994
• UDI-Public: 00885074035994
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2017

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 3289002
• Device Lot Number: OT10B003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/16/2017
• Supplement Date Received by Manufacturer: 02/16/2017
• Initial Report FDA Received Date: 03/15/2017
• Supplement Report FDA Received Date: 10/02/2017
• 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: Other
• Patient Age: 46 YR