MAUDE Adverse Event Report: SYNTHES USA; TRACTION, APPARATUS, NON-POWERED

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

Patient Problems Loss of Range of Motion (2032); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.H10 additional narrative: b3: eingartner, c et al(1998).Distalization of the patella during tibial callus distraction.Archives orthopaedic trauma surgery, 117: 397-398.D1, d2, d3, d4: this report is for an unknown external fixator/unknown quantity/unknown lot.D4: unknown part number, udi unavailable.H3, h4, h6: the investigation could not be completed and no conclusion could be drawn, as no device was returned.Without a lot number, a device history record review could not be conducted.H6: 3191 patient code refers to knee joint distalization of the patella.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Literature article received: this report is being filed after the subsequent review of the following literature article eingartner, c et al(1998).Distalization of the patella during tibial callus distraction.Archives orthopaedic trauma surgery, 117: 397-398.This article reports a case study of a (b)(6) woman who was treated for a grade iii a open lower leg fracture in january 1996.She was admitted to the hospital in march 1996 with a suppurating infection and underwent a soft-tissue reconstruction, osseous debridement, and a segmental resection involving tibial corticotomy below the tibial tuberositas, application of a modified ao external fixator, and initiation of segmental transportation.Consecutive x-ray series demonstrated good bone formation in the distraction zone and regular alignment of the transport segment.However, it also showed an increasing distalization of the patella.It was reported that the patient's range of motion was increasingly reduced with respect to flexion.This is report 1 of 1 for com-275208.This report is for an unknown ao external fixator.This is report 1 of 1 for com-275208.

• Type of Device: TRACTION, APPARATUS, NON-POWERED
• 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: 6507710
• MDR Text Key: 73266572
• Report Number: 2520274-2017-11396
• Device Sequence Number: 1
• Product Code: HST
• 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: Health Professional
• Type of Report: Initial
• Report Date: 03/24/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2017
• Initial Date FDA Received: 04/20/2017
• 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: 42 YR