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 03/20/2017

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.(b)(4).Explant date: not explanted.Device is not expected to be returned for manufacturer review/investigation.(b)(6).(b)(4): this event will be captured as use error.The severity of this event was categorized as moderate.Moderate was defined as mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention/therapy required.(b)(4): there is no allegation at the time of this review that the product malfunctioned and the reported event is likely a result of a technical issue.This event will be captured as use error.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 on (b)(6) 2015 the patient had a philos without augmentation surgery.It was noted during the initial procedure that there was "poor intra-op fracture reduction" one year post-operative the patient experienced limited function due to poor reduction and impingement.The patient recovered with persistent damage (slightly limited range of motion).It is unclear if the patient will recover completely.Recovery in progress.The severity was reported as moderate (moderate: mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention/therapy required).No revision surgery was performed.The poor fracture reduction intra-operative led to impingement and limited range of motion post-operative.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: 6583753
• MDR Text Key: 75715636
• Report Number: 9612488-2017-10224
• 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

• Date FDA Received: 05/22/2017
• 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
• Date Manufacturer Received: 05/03/2017
• 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