MAUDE Adverse Event Report: SYNTHES RARON 3.5MM TI LCP® PROXIMAL HUMERUS PLATE-STANDARD 5H SHAFT/114MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT

Catalog Number 441.903

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that six weeks after the initial surgery while the patient was doing rehab, she heard a crack and felt pain.When the x-ray were taken it was possible to see two screws broken around the head and a third screw pulled out.This is report 4 of 4 for (b)(4).

Manufacturer Narrative

Weight is an approximation.Reported as (b)(6) 2015 but it unknown when exactly the device pulled out.(b)(6).The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A review of the device history records has been requested.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

Additional narrative: device history records was conducted.The report indicates that the: manufacturing site: (b)(4), manufacturing date: 13.Jan.2015, no ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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

A manufacturing investigation action was conducted/performed.The report indicates that the: our investigation has shown that the thread flanks of the first distal and the third distal locking hole are damaged.These damages make a proper locking of the locking screw impossible, also the relevant dimensions can therefore not be verified anymore.The anodized layer is completely worn out at the damages, which indicates that they were caused post-manufacturing.However, afterwards it is not possible to determine if this occurred during the insertion, extraction or the strong displacement of the plate, which is visible on the received in-situ picture, after the screws were broken.All other threads of the plate are in a good condition and the enclosed locking screws can be locked as required.Complaint is unconfirmed for the plate as alternating bending loads (two-sided).Constantly alternating load cycles (during movement) led to the fatigue of the material and finally to the screw fracture.An investigation summary was performed.The investigation of the complaint articles has shown that: the investigation of the plate has shown that some of the locking threads are damaged.This was caused post-manufacturing, but afterwards it is not possible to determine if this occurred during the insertion, extraction or the strong displacement of the plate, which is visible on the received in-situ picture, after the screws were broken.This strong displacement of the plate could also be the reason of the mentioned screw back out.No product related fault could be detected.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

Alert date update, reported as (b)(6) 2015.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.

• Brand Name: 3.5MM TI LCP® PROXIMAL HUMERUS PLATE-STANDARD 5H SHAFT/114MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT
• Manufacturer (Section D): SYNTHES RARON; kanalstrasse west 30; raron CH394 2; SZ CH3942
• Manufacturer (Section G): SYNTHES RARON; kanalstrasse west 30; raron CH394 2; SZ CH3942
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4737605
• MDR Text Key: 5888950
• Report Number: 3006126083-2015-10032
• 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,company representati
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 441.903
• Device Lot Number: 9301985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 60