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

Model Number	25-878-07-91
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/27/2017
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: SCREW
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 6522899
• Report Number: 9610905-2017-00041
• Device Sequence Number: 16444530
• Product Code: HRS
• UDI-Device Identifier: 00888118047731
• UDI-Public: (01)00888118047731
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K971297
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Model Number: 25-878-07-91
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/27/2017
• Supplement Date Received by Manufacturer: 03/27/2017
• Initial Report FDA Received Date: 04/26/2017
• Supplement Report FDA Received Date: 09/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other