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

Catalog Number 241.901

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Type  Injury  

Event Description

It was reported that the patient underwent revision surgery on (b)(6) 2015 due to fixation failure.The patient also had complaints of pain and instability.It was also reported that three distal cortex screws were pulling out of the bone.The patient was initially implanted with one 3-hole 3.5 mm locking compression plate (lcp) proximal humerus plate, eight 3.7 mm cannulated locking screws and three 3.5 mm cortex screws on (b)(6) 2015 to treat a three part proximal left humeral fracture.The 12 implants were removed from the patient during the (b)(6) 2015 revision surgery.The implants were removed easily and without additional intervention or unanticipated surgical delay.The patient was successfully revised with a 7-hole 3.5 mm lcp proximal humerus plate and associated hardware.The patient¿s outcome was reported as ¿good.¿ this is report 1 of 12 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: event date: unknown.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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.

• Brand Name: 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBON, SINGLE COMPONENT
• Manufacturer (Section D): SYNTHES RARON; kanalstrasse west 30; raron CH39 42; SZ CH3942
• Manufacturer (Section G): SYNTHES RARON; kanalstrasse west 30; raron CH39 42; SZ CH3942
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4753194
• MDR Text Key: 19982491
• Report Number: 3006126083-2015-10034
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 241.901
• Device Lot Number: 9220820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 84