MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ELBOW HINGE FIXATOR; APPLIANCE,FIXATION,NAIL

Model Number	394.055
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device malfunction did occur and regardless of misuse, has caused or contributed to the need for medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that a patient had a procedure on (b)(6) 2017 for a fracture of coronoid.Post-operatively, the joint of the hinge on the elbow fixator fell apart.Revision for hardware removal was performed on (b)(6) 2018 where the elbow fixator was removed and new parts were implanted.There was no surgical delay.Patient status/outcome was successful and procedure was completed successfully.This complaint involve 1 part.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Additional product code: lxt.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
A device history record (dhr) review was performed for part # 394.055, synthes lot number: l270608: manufacturing location: (b)(4), release to warehouse date: 30.Mar.2017, no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product development investigation was performed for the subject device.The device was returned with the complaint condition stating the returned device was received at customer quality (cq) disassembled in three pieces and missing the locking nut which retains the center pin.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition.The complaint has been confirmed.The elbow hinge fixator (394.055) is a supplemental component which can be utilized with both the medium and large external fixation systems for unstable elbow fractures.It is able to be utilized with both rigid and movable fixation setups and is able to be located at the anatomical pivot due to its radiolucent construction.The device allows for guided mobilization of the elbow joint or can be locked into position by bridging with an additional rod.A dimensional inspection could not be performed at cq because the nut was not returned and dimensional are not applicable.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The material and relevant material properties were determined to be conforming at the time of manufacture based on review of the dhr.The applicable drawing for the elbow fixator was reviewed during this investigation.No product design issues or discrepancies were observed.A definitive root cause for this complaint could not be determined based on the provided details.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ELBOW HINGE FIXATOR
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA
• MDR Report Key: 7214255
• Report Number: 2939274-2018-50378
• Device Sequence Number: 16403098
• Product Code: KTT
• UDI-Device Identifier: 10886982199478
• UDI-Public: (01)10886982199478(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K090658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/04/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 394.055
• Device Catalogue Number: 394.055
• Device Lot Number: L270608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Initial Date Received by Manufacturer: 01/04/2018
• Supplement Date Received by Manufacturer: 02/26/2018; 04/04/2018
• Initial Report FDA Received Date: 01/23/2018
• Supplement Report FDA Received Date: 02/27/2018; 04/05/2018
• 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
• Patient Age: 26 YR
• Patient Weight: 91