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

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

Patient Problems Unspecified Infection (1930); Pain (1994); Staphylococcus Aureus (2058); Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not for diagnosis.Richamond, j; etal (2004), nonunions of the distal tibia treated by reamed intramedullary nailing, j orthop trauma 18: 603-610.This report is for an unknown nail (unknown quantity/unknown lot).Udi: unknown part number, udi is unavailable.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no device was returned and no lot number or part number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after subsequent review of the following literature article: richamond, j; etal (2004), nonunions of the distal tibia treated by reamed intramedullary nailing, j orthop trauma 18: 603-610.The purpose of this study is to determine the efficacy of reamed intramedullary nailing in the treatment of nonunions of the distal one-fourth of the tibia.Nonunions of the distal tibia are particularly difficult to treat given the short distal segment, the proximity to the ankle joint, and the fragile soft-tissue envelope.Intramedullary nailing is an attractive solution to this problem because it avoids extensive dissection, and the implant remains intraosseous, posing minimal problem for the soft tissues.Thirty-two patients (23 males and 9 females, average age of 43 years) with nonunions of the distal one fourth of the tibia who were treated by reamed, locked intramedullary nailing over a 10-year period (1992¿2002) at a single institution were identified in a fracture database.Data was collected by retrospective chart and radiograph review.All necessary instrumentation was removed first.Next, schanz pins for the large femoral distractor (synthes, paoli, pa) were placed under fluoroscopy parallel to the knee and ankle joints, as far proximally and distally as possible, with the distractor placed on the concave side if coronal plane deformity was present.Average length of follow-up was 25 months (range 4¿81 months).Twenty-nine out of 32 patients achieved union at an average of 3.5 months after reamed, locked intramedullary nailing.Of the remaining three, 2 patients united after dynamization (one at 4 months after dynamization and the other at 7 months), and the third patient united 4 months after exchange nailing.Deformity was corrected to a maximum of 4° in all planes.Seven patients had a history of infection, but no patients had signs of active infection at the time of surgery.Four patients had positive intraoperative cultures, and only 2 required removal of the nail after achieving union to control infection.There were no signs of chronic osteomyelitis in these 2 patients at the date of the last follow-up visit; 5.5 years and 2 years following nail removal.Reamed, locked intramedullary nailing is a reliable and safe procedure in the treatment of nonunions in the distal one fourth of the tibia, even in the setting of prior infection or external fixation.It allows for excellent correction of deformity, which is an essential component of the procedure.This is report 4 of 4 for (b)(4).This report is for an unknown reamed intramedullary nailing and refers to the serious injury for case #32, (b)(6) female patient who experienced pain, revision, debridement, removal of nail after union due to staphyloccocus aureus infection.

• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5398152
• MDR Text Key: 37088050
• Report Number: 2520274-2016-10473
• 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,litera
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• 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: 01/13/2016
• 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
• Patient Age: 49 YR