MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LARGE EX-FIX COMBINATION CLAMP MR-CONDITIONAL; APPLIANCE,FIXATION,NAIL

Model Number	390.005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Patient id, age, dob and weight not provided for reporting.Unknown when the c-spine (cervical spine) mri was attempted.Additional product code: lxt.Complainant part is not expected to be returned for manufacturer review/investigation.Additional 510k #'s:k122455, k082650, k033158, k030390.(b)(4).Dhr review could not be conducted due to insufficient information.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.If additional is obtained that was not available for the initial med-watch, the investigation will be updated as applicable, and a follow-up med-watch will be filed as appropriate.
Event or Problem Description
It was reported that a patient with an ex-fix device experienced a magnetic pull from being in the vicinity of magnetic resonance imagining (mri) and the scan was not performed as a result.The patient was not put into the machine.This was a poly-trauma (post motorcycle accident) patient who was intubated and had a pelvic ex-fix in place since a procedure on (b)(6) 2018.He was to have a c-spine (cervical spine) mri.The patient was observed to be kicking his legs (he was in pain) in relation to being in the mri area; being near the machine was enough to cause a "pull" on his ex-fix device.The plan for the mri was aborted; no mri was done.The patient was returned to the operating room for an uneventful procedure on (b)(6) 2018 at which time the ex-fix was removed.This complaint involves seven devices, this report is 2 of 7 for (b)(4).

• Brand Name: LARGE EX-FIX COMBINATION CLAMP MR-CONDITIONAL
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7427483
• Report Number: 2939274-2018-51633
• Device Sequence Number: 19140899
• Product Code: KTT
• UDI-Device Identifier: 10886982197825
• UDI-Public: (01)10886982197825(10)LOTUNK
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K161417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2018

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 Model Number: 390.005
• Device Catalogue Number: 390.005
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 04/12/2018
• 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: Required Intervention