MAUDE Adverse Event Report: SYNTHES USA; NAIL, FIXATION, BONE

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Loss of Range of Motion (2032); Fracture, Arm (2351); Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Event Description

It was reported that the patient had a badly broken left arm.On (b)(6) 2013, a humeral head and shaft plate with multiple compression screws were implanted.The patient was then referred to physical therapy by the surgeon.Despite attending physician therapy, the patient¿s fracture failed to progress.It was around (b)(6) 2013 when the surgeon discovered that the surgical hardware used was the wrong size and/or was placed in the wrong position.On (b)(6) 2013, a revision procedure to remove the wrong hardware was performed and the incision was closed.Soon after, the surgeon rotated the patient¿s left arm and applied traction causing a comminuted long spiral fracture to the soft humerus bone.On an unknown date, the surgeon re-opened the closed incision to attempt to repair the fracture.During this procedure, smaller hardware was also implanted.It was reported that the patient's left arm will not fully recover.This report is for one (1) unknown humeral head.This report is 1 of 3 for (b)(4).

Manufacturer Narrative

Patient date of birth and weight are unknown.The discovery of the mis-sized/mis-placed implant was around (b)(6) 2013.This report is for one (1) unknown humeral head.(b)(4).Unknown as no part or lot numbers were provided for the complainant part.Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number or part number was provided.Device 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.

• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4595115
• MDR Text Key: 5483199
• Report Number: 2520274-2015-11766
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 03/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention