MAUDE Adverse Event Report: SYNTHES USA; PIN, FIXATION, SMOOTH

Device Problem Failure to Osseointegrate (1863)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Sidky, a., md, msc and buckley, r.E., md (2008).Hardware removal after tibial fracture has healed.Can j surg.51(4):263-268.This report is for an unknown locking bolt.(other number) udi: unknown part number, udi is unavailable.(b)(4) the 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 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 Description

This report is being filed after subsequent review of the following journal article, sidky, a., md, msc and buckley, r.E., md (2008).Hardware removal after tibial fracture has healed.Can j surg.51(4):263-268.The authors undertook a retrospective chart review of a single surgeon's practice from january 1996 to february 2005.They identified patients aged 16-70 years with a tibial fracture treated with an intramedullary nail (imn).The imn used was a titanium locked reamed tibial nail (either synthes or depuy ace).They identified 130 patients with 134 tibial fractures who met both inclusion and exclusion criteria; 4 patients had bilateral tibial fractures.Patients were followed until fracture union and/or request for imn removal.Removal was considered to be the removal of any portion of the imn - either locking bolt(s) alone or the entire imn (nail and locking bolts).There were a total of 12 nonunions (of the 130 patients); 2 patients had bone grafting, 2 patients had nail dynamization performed, and two underwent nail exchange.Overall, 40 patients with 42 fractures (31.3% of all the fractures; 24 male and 18 female) had a second operative procedure for implant removal.Locking bolts were removed in 33.3% (14/42) of the fractures, and the entire imn was removed in 66.6% (28/42).Among the locking bolts (14 fractures in 14 patients), 14.3% (2/14) were removed owing to dynamization of the imn (delayed union or nonunion) and 85.7% (12/14) were removed because of implant pain due to the locking bolt.Among the removed imns (28 fractures in 26 patients), 60.7% (17/28) were removed owing to pain surrounding the implant, 28.6% (8/28) were removed to exchange a nail because of delayed or nonunion, 7.1% (2/28) were removed owing to infection, and 3.6% (1/28) removed because there was a periprosthetic fracture.This left 29 patients with 29 fractures who had their imn removed for symptomatology (including anterior knee pain, tibial pain, and pain over locking bolt sites).In all patients, the indication listed for removal was a combination of either pain (anterior knee or leg pain) or prominence surrounding their implant (locking bolt prominence).Twelve patients (7 male, 5 female) had the locking bolt only removed; seventeen patients (8 male, 9 female) had the entire imn removed (table 2).This report is for an unknown locking bolt and refers to a male patient with locking bolt removal due to pain and prominence.This is report 20 of 30 for (b)(4).

• Type of Device: PIN, FIXATION, SMOOTH
• 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: 5420589
• MDR Text Key: 38044228
• Report Number: 2520274-2016-10833
• Device Sequence Number: 1
• Product Code: HTY
• 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,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/14/2016

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
• Device Operator: Health Professional
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2016
• Initial Date FDA Received: 02/09/2016
• 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