MAUDE Adverse Event Report: SYNTHES USA; ROD, FIXATION, INTRAMEDULLARY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fracture, Arm (2351); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Patient weight is unknown.Exact date of post-operative non-union is unknown.This report is for one (1) unknown 4.0mm locking screw.(other): without a valid part and lot number, the udi is not available.The complainant part is not expected to be returned for manufacturer review/investigation.Unknown, as specific part and lot numbers for the complainant locking screw were not provided.However, a possible 510k is k103002.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.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.

Event Description

It was reported that a patient underwent a revision procedure on (b)(6) 2016 due to a secondary fracture and non-union.The patient originally sustained a fracture of the left humerus following a fall in (b)(6) 2015.The injury was treated on (b)(6) 2015 with the insertion of an expert humeral nail, a spiral blade, an end cap, and a 4.0mm locking screw.On an unknown date in (b)(6) 2016, the patient suffered another fall and re-fractured the left humerus.The new fracture was distal to the previously implanted humeral nail.The distal fractured bone, below the nail inserted, healed appropriately; however, the humerus bone that contained the original humeral nail had not (non-union/delayed healing).As a result, the patient was returned to the operating room on (b)(6) 2016 for an open reduction internal fixation (orif) procedure utilizing a 6-hole humeral plate with bone graft.The surgeon noted that the original nail had maintained good position and that removal was completed without issue.Post-operatively, the patient was noted to be in stable condition.This report is for one (1) unknown 4.0mm locking screw.This report is 4 of 4 for (b)(4).

• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5818948
• MDR Text Key: 50323023
• Report Number: 2520274-2016-13621
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2016
• 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