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

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

Patient Problems Unspecified Infection (1930); Discharge (2225); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Kulshrestha, v (2008) incidence of infection after early intramedullary nailing of open tibial shaft fractures stabilized with pinless external fixators.Indian journal of orthopaedics, 42(4): 401¿409.This report is for an unknown ao pinless fixator (unknown quantity/unknown lot).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.(b)(4).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: kulshrestha, v (2008) incidence of infection after early intramedullary nailing of open tibial shaft fractures stabilized with pinless external fixators.Indian journal of orthopaedics, 42(4): 401¿409.This study is a retrospective review of 30 cases of open diaphyseal fractures of the tibia of varying severity that were managed at our institute from 2001 to 2003 with primary stabilization with ao pinless fixator.The mean age of the patients was 34.9 years (ranged 21 to 60 years).All the cases included in the study had a staged treatment (primary external fixation followed by intramedullary nailing) because of either delayed presentation or multiple associated injuries.Cases that had less than two-year follow-up were not included in the study.In all the cases, the pinless fixator was applied within 8 hours of hospital admission.The ao pinless external fixator includes three different clamp designs.For the proximal metaphyseal fixation, large clamps were used; for the midshaft, the asymmetric ones were used; and for distal fixation, the small ones were used.The fixator was applied under spinal anesthesia.Individual clamps were inserted through stab incision with the aid of locking handle.In ao type a and b fracture pattern, the pinless fixator ensured reasonable stability permitting early mobilization in the postoperative period.In all other cases ao type b and c fractures, unreamed interlocking titanium nail ((b)(4)) was used.The fixator was removed after the nail was in situ; the distal locking was performed first to enable compression/distraction at the fracture site if required.In six patients (20%), there was a discharge from the clamp site, which was cured by curettage of the outer cortex and oral antibiotics for a short period.This did not affect the result of exchange nailing.In most of the cases (27 out of 30), pinless fixator provided reasonable stability to the fracture, and the patient was able to perform almost full range of knee and ankle movements.In three cases (10%), pinless fixator could not ensure reasonable stability, and all these cases had complex fracture anatomy (ao type 42c).In these cases, full range of knee and ankle movements were not permitted, and additional protection was provided in the form of immobilization over bohler braun splint.Ambulation was not permitted in all these cases.A copy of the literature article will be attached to the medwatch.This report is 2 of 7 for (b)(4).This report is for an unknown ao pinless fixator and refers to the serious injury of case 7, (b)(6), clamp site discharge, currette, superficial soft tissue infection due to the clamp.

Manufacturer Narrative

Received by manufacturer date was previously reported as 4/4/17.The correct date is 5/10/2017.Device used for treatment, not for diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Alert date changed from (b)(6) 2017.Device used for treatment, not for 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: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6497293
• MDR Text Key: 72921677
• Report Number: 2520274-2017-11336
• Device Sequence Number: 1
• Product Code: KTT
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2017
• 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: 33 YR