MAUDE Adverse Event Report: SYNTHES USA; PROSTHESIS, ELBOW, HEMI-RADIAL , POLYMER

Device Problems Break (1069); Material Rupture (1546)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient dob & weight not available for reporting.Event date: unknown.Unk-product - with limited and or no information on the part, additional product codes to include: hsd, kwt, kwy, mdi , mjo, nei.This report is for an unknown prosthesis/unknown lot number.Other: udi: unknown part number, unknown lot number, udi is unavailable.Implant and explant dates: unknown when implanted or explanted.Code used for: this device was reported as ruptured and required additional surgical intervention to replace the device.Pm 510k#: unknown.Subject device has not been received.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

Device report from synthes on an event in (b)(6) as follows: it was reported that the hospital bought a prosthesis to be used in a surgery but it broke on the day of the procedure.Additional information received from translated formal letter on (b)(6) 2016 via e-mail: on the day of the operation the prosthesis ruptured and as a result, had to be replaced with a different one at that time.More information forth coming 20apr2016.This complaint involves 1 part.This report is 1 of 1 for.

• Type of Device: PROSTHESIS, ELBOW, HEMI-RADIAL , POLYMER
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5555709
• MDR Text Key: 42143701
• Report Number: 2520274-2016-12015
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2016
• 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