MAUDE Adverse Event Report: SYNTHES BETTLACH PHILOS 3.5 3HO SST; APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT

Catalog Number 241.901

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 01/27/2015

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient age, dob & weight not provided for reporting.(b)(4).Not explanted.Device is not expected to be returned for manufacturer review/investigation.(b)(6).(b)(4).Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the patient had a philos with augmentation surgery on (b)(6) 2015.The patient recovered with persistent damage.Persistent damaged was described as one year post-operatively the patient has limited function due to poor reduction and impingement.The impingement was expected due to severity of the fracture.The initial surgery was due to a fall on (b)(6) 2015.Per the adverse event form from the study: the severity was moderate (moderate: mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention/therapy required).The poor fracture reduction intra-operative led to impingement and limited range of motion post-operative.No revision surgery was performed.This complaint involves 2 parts.This report is 1 of 2 for (b)(4).

• Brand Name: PHILOS 3.5 3HO SST
• Type of Device: APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6586106
• MDR Text Key: 75796281
• Report Number: 9612488-2017-10225
• Device Sequence Number: 1
• Product Code: KTW
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K011815
• 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
• Report Date: 05/03/2017

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 241.901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/03/2017
• Initial Date FDA Received: 05/23/2017
• 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