MAUDE Adverse Event Report: SYNTHES USA LCP-T-PL-3.5 R-ANGL SHAFT 4HO HE 4HO L56

Catalog Number 441.141

Device Problems Partial Blockage (1065); Difficult to Remove (1528); Failure to Disconnect (2541)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2013

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: during a removal osteosynthesis surgery, it was impossible to unscrew the screws of the plate (screws blocked).The screw heads were destroyed with a drill in order to remove the plate.There was an extension of delay of surgery.Fragments remain in the soft tissue.No clinical consequence in intraoperative.This is report 1 of 4 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Date of implant unknown.Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number was provided.Placeholder.

Manufacturer Narrative

Note: blank fields on this form indicate information that is unknown, unavailable or unchanged.

Manufacturer Narrative

An evaluation was performed on the returned product.The received plate is broken at the shaft, at the fracture face the plate was damaged, and locking holes are badly damaged.The relevant dimensions of the locking screws can not be measured as the screw heads were drilled out for removal.Also the locking threads in the plate can not be evaluated due to damage during removal.The examination of the raw-material testing certificates and the manufacturing records showed no deviations regarding material analysis, strength and structural stability at the time of manufacture.The damage can be contributed to excessive force that was required for removal.Therefore, this complaint has been deemed indeterminate from a manufacturing perspective.

Manufacturer Narrative

Additional narrative: review of the device history record showed there were no issues during the manufacture of the product that would contribute to this complaint condition.Lot number 2800495.

• Brand Name: LCP-T-PL-3.5 R-ANGL SHAFT 4HO HE 4HO L56
• Manufacturer (Section D): SYNTHES USA; west chester PA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3595225
• MDR Text Key: 16801528
• Report Number: 2520274-2014-00328
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K000684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 441.141
• Device Lot Number: 2800495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2014
• Initial Date FDA Received: 01/28/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/28/2014; 07/08/2014; 07/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1