MAUDE Adverse Event Report: SYNTHES USA 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/75MM; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.231.275

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Type  Injury  

Event Description

It was reported the patient had hardware failure which required a revision procedure on (b)(6) 2015.Per operating room (or) reports, the original surgery was an open reduction internal fixation (orif) procedure for a left femur periprosthetic fracture.This original procedure took place on (b)(6) 2015.The or reports indicated that "¿the proximal screw was then placed with the targeting guide.The screw was found to have missed the plate.The screw was then removed.The screw was then re-inserted and confirmed to be through the plate." a review of the records of utilized hardware determined the unknown screws to be 5.0 mm locking screws.Additionally, the records show that there was a quantity of 4 (four) 5.0mm locking screws implanted.Since that original procedure, the patient has fallen twice.During the revision procedure, the plate was noted to be bent.All of the devices were removed without complications or surgical delay.This report is 4 of 10 for (b)(4).

Manufacturer Narrative

Additional narrative: additional patient information: patient¿s height was reported as (b)(6).Patient initials are (b)(6).Event date: unknown.Additional product codes for this report include hrs and hwc.Product investigation evaluation: the complaint condition for the 4.5mm variable angle lcp curved condylar plate was likely caused by the impact of the patient falling; however, this complaint is not a result of any design related deficiency.No product issue was identified in the complaint or noted upon examination of the four (4) returned 4.5mm cortex screws and five (5) 5.0mm variable angle locking screws.The 4.5mm variable angle lcp curved condylar plate, four (4) 4.5mm cortex screws, and five (5) 5.0mm variable angle locking screws are implants routinely used in the 4.5mm va-lcp curved condylar plate system.The five returned 5.0mm variable angle locking screws were received in worn condition consistent with insertion, implantation for an extended period of time, and removal.All five screws show gouges along their length consistent with the returned plate becoming forcibly bent.The associated drawing was reviewed and determined to be suitable for the intended design, application, and dimensional conformity when used as recommended.No product issue was identified in the complaint description or noted upon examination.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

It was reported that an ortho distracter was used in surgery.It was also noted that two (2) screws were wasted during the procedure.The patient was admitted to a rehabilitation facility.The provided x-rays were reviewed by the manufacturer and it was noted that a screw pulled out and hardware failure.This is report 4 of 11 for (b)(4).

• Brand Name: 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/75MM
• Type of Device: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4744941
• MDR Text Key: 5709356
• Report Number: 2520274-2015-13566
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.231.275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 113