MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG LEVEL ONE CMF; SCREW

Model Number 25-878-07-91

Device Problems Sticking (1597); Material Integrity Problem (2978)

Patient Problem Failure of Implant (1924)

Event Date 03/27/2017

Event Type  Injury  

Event Description

When the doctor was putting the plate on to the segmentalized fibula bone after pre-drilling the holes, the 7 mm screws partially threaded before becoming stuck in the bone.Increased force on the screwdriver to mobilize screws caused the screw heads to strip and they became unusable.Doctor was forced to remove the screws with a wire-driver, and one of the screw heads broke off from the threads.The doctor had to move the plate to a non-ideal location slightly below the previous screw holes in order to fixate the plate while avoiding the stripped screw body.Patient is doing well and no other adverse effects from this incident have been reported at this point.

Manufacturer Narrative

An investigation was performed on the basis of complaint statistics as no device was returned for evaluation.The complaint percentage was calculated and it is determined that the complaint percentage falls within the design risk limits adhered to at klm.The review of the device history records was not possible due to no lot number being provided.The failure root cause cannot be determined due to no device being returned.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.

• Brand Name: LEVEL ONE CMF
• Type of Device: SCREW
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• Manufacturer (Section G): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• Manufacturer Contact: jennifer damato ; p.o. box 16369; jacksonville, FL 32245 ; 9046417746
• MDR Report Key: 6522899
• MDR Text Key: 73757674
• Report Number: 9610905-2017-00041
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888118047731
• UDI-Public: (01)00888118047731
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971297
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 25-878-07-91
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other