MAUDE Adverse Event Report: SYNTHES USA 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT

Catalog Number 241.901

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: a philos plate was used during the initial procedure; all locking screws were tightened by a torque screwdriver.When the patient re-visited for post-operative consultation three weeks after the surgery, x-ray showed that an ascending locking-screw was found to be backed out.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Unknown if device has been explanted.(b)(6).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Patient information is not available for reporting.Device used for treatment, not diagnosis.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

(b)(6) 2015: we have below 5 screws, but the x-ray shows 8 screws, the other three are 3.5 cortical screws and they are implanted along the shaft and not at the proximal humerus area.Patient is complaining the design of the philios plate which caused the locking screw back out instead of the cortical screws.Out of the five 3.5 locking head screws reported, the longest one would be 50mm.Please kindly refer to the x-ray and the backed out screw should be the longest one, the longest reported we have is part # 213.0.This screws has been used, but not known, which one backed out post op: part # 213.035 / quantity 2.Part # 213.030 / quantity 1.Part # 213.050 / quantity 1.Part # 213.040 / quantity 1.

• Brand Name: 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT
• 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: 4592199
• MDR Text Key: 5630726
• Report Number: 2520274-2015-11710
• Device Sequence Number: 1
• Product Code: KTW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK011815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2015
• Is this an Adverse Event Report?: No
• 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?: Yes
• Date Manufacturer Received: 04/23/2015
• 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