MAUDE Adverse Event Report: SYNTHES GRENCHEN LCP 3.5 12HO L163 TI; APPLIANCE,FIXATION,NAIL

Catalog Number 423.621

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369)

Event Date 06/23/2013

Event Type  Injury  

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.

Manufacturer Narrative

Device was used for treatment, not diagnosis.The investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system.A review of the device history records was performed and no complaint related issues were found.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: on (b)(6) 2013, it was reported that the patient suffered an accident which resulted in an open fracture of the forearm among other injuries, scaphoid and femur fractures.On (b)(6) 2013, the patient was operated on and inserted with two titanium locking compression plates with twelve holes.On (b)(6) 2013, the patient became unbalanced and fell onto the grass.As i result the locking compression plate system was bent almost to ninety degrees.On (b)(6) 2013, the patient suffered another surgical intervention that bent the locking compression plates which were removed and the patient was inserted with two new locking compression plates with ten holes.This second surgery took approximately three to four hours.X-rays and photos were taken before and after both surgeries.This report is for 1 of 2 complaint (b)(4).

Event Description

Per additional information received from an x-ray review performed by the medical director; it was determined that the fracture demonstrates delayed healing.This report is for 2 of 2 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional information: x-ray review.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LCP 3.5 12HO L163 TI
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): SYNTHES GRENCHEN; solothurnstrasse 186; grenchen CH25 40; SZ CH2540
• Manufacturer (Section G): SYNTHES GRENCHEN; solothurnstrasse 186; grenchen CH25 40; SZ CH2540
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3660011
• MDR Text Key: 11907455
• Report Number: 3009450884-2014-10001
• Device Sequence Number: 1
• Product Code: KTW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK000684
• 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
• Report Date: 02/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 423.621
• Device Lot Number: 8339888
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/08/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR
• Patient Weight: 75