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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Giannoudis, p.V.Et al (2000) simultaneous bilateral femoral fractures: systemic complications in 14 cases.International orthopaedics (sicot) 24:264-267.This report is for unknown nail, unknown quantity, unknown lot.(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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

Literature article received.This report is being filed after the subsequent review of the following literature article.Giannoudis, p.V.Et al (2000) simultaneous bilateral femoral fractures: systemic complications in 14 cases.International orthopaedics (sicot) 24:264-267.Between january 1993 and march 1999 300 consecutive adult patients with femoral shaft fractures were treated in a unit.Among them there were 14 patients (1 female) identified with simultaneous bilateral femoral shaft fractures (bfsf).Another group of 40 patients (7 women) randomly selected from the database with unilateral femoral shaft fractures, formed the control group of the study.The mean age in the bfsf group was was 38.2 (19-75) years and 42.4 (18-85) years in the control group.No significant difference was noted between the two groups regarding age and sex.The median injury severity score (iss) of the bfsf group was 16 (10-20) compared to 9 (9-10) of the unilateral femoral fracture group.In 8 patients (15) ao hollow nails were inserted after preparation of the medullary cavity with reaming.In the remaining 6 patients, 12 solid femoral nails (ao) inserted with an undreamed technique.A 9-mm solid nail (ufn) was inserted on each occasion.In the bfsf group there was 1 case of osteomyelitis and 1 above-knee amputation due to deep sepsis.In the control group there was 1 case of compartment syndrome and 1 failure of hardware.This is report 2 of 2 for (b)(6).This report is for an unknown nail and refers to 1 case of failure of hardware.

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4): the recurrence of the device malfunction is likely to cause or contribute to a death or serious injury if it were to recur.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Date received by manufacturer: may 27, 2016.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5716932
• MDR Text Key: 47206687
• Report Number: 2520274-2016-13095
• Device Sequence Number: 1
• Product Code: JDS
• 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: 05/27/2016

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?: Yes
• Device Operator: Health Professional
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/27/2019
• Initial Date FDA Received: 06/10/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/13/2016; 06/14/2016
• 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