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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Müller, c.A., dietrich, m., morakis, p., and pfister, u.(1998).Clinical results of the primary fixation of open tibial fractures treated with the unreamed ao/asif tibial nail.Der unfallchirurg.101(11): pp 830-837 this report is for an unknown locking bolt/unknown lot/quantity unknown.(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, m܌ler, c.A., dietrich, m., morakis, p., and pfister, u.(1998).Clinical results of the primary fixation of open tibial fractures treated with the unreamed ao/asif tibial nail.Der unfallchirurg.101(11): pp 830-837.Germany article.Between april 1991 and june 1996 our hospital treated 69 open tibial shaft fractures primarily with an unreamed synthes tibial medullary nail (utn).The criteria for inclusion in the prospective study was a tibial shaft fracture on the one hand and extra-articular proximal and distal tibia fractures on the other hand, in as far as two locking bolts could be inserted in the metaphysial fragment.Sixty-five patients (47 were male and 18 female) with 69 fractures met the study criteria.The median ages was 29 (17-77) years of ages and the body height was 176 cm (155-195) and median weight of 75 kg (48-115); 52 patients had no pre-existing conditions, the remaining 16 patients the most common conditions was alcohol/drug/prescription drug abuse at 8/16 patients followed by cardiovascular conditions in 6/16, diabetes was 1/16 and bronchial asthma at 1/16.The criteria for clinical fracture healing were a pain-free gait and the radiological fracture healing was a callus bridge with three of four cortices.A delayed fracture healing is when no callus bridges are formed within 24 weeks.Pseudarthrosis was when no fracture healing could be found after 40 weeks.Post-surgery (median 8 days) 3 patients suffering multiple trauma died.The follow-up examination was thus possible for 62 patients with 65 fractures.Early dislocation with diastasis formation meant that one patient with significant osteoporotic tibial malposition needed to have the medullary nail removed four days after the operation.The cause of the early dislocation was a loosening of the locking bolts.On the day of the operation a medullary nail was found to be too long and had to be replaced.A malposition meant another patient had to have a locking bolt removed 1 day post-surgery.There was delayed healing in three fractures requiring secondary conversion to reamed nailing.Eight fractures developed pseudarthrosis of which five healed uneventfully.Deep infections were manifest in four fractures.Three of these infections developed after secondary intervention to treat pseudarthrosis.Seven of the eight pseudarthrosis and three of the four infections healed eventually.Revision procedures were necessary in 11 patients to deal with disturbed fracture healing or infection (10 reamed nailing procedures, three cancellous bone grafts, and one of each of the following: sequestrectomy, fibular osteotomy, plate fixation, external fixator, monorail procedure).Another deep infection arose of after sequestrectomy 4 months post-surgery with delayed fracture healing, so that 4.5 months post-surgery the utn had to be removed and the septopal chain needed to be applied.In 6/65 fractures clinically relevant malpositions resulted (3 proximal and three distal fractures).Three fractures had a primary malposition; the other three had a secondary dislocation.Of the 220 implanted lock bolts, 26 (18 distal, 8 static proximal bolts), broke in 15 patients.This report is for an unknown locking bolt and refers to early dislocation with diastasis formation in one patient with significant osteoporotic tibial malposition who needed to have the medullary nail removed four days after the operation.The cause of the early dislocation was a loosening of the locking bolts.A malposition meant another patient had to have a locking bolt removed 1 day post-surgery.Of the 220 implanted lock bolts, 26 (18 distal, 8 static proximal bolts), broke in 15 patients.This is report 2 of 2 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: 5463289
• MDR Text Key: 39125912
• Report Number: 2520274-2016-11331
• 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: 02/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2016
• 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