MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG MAXDRIVE MINI SCREW; BONE SREW

Model Number	25-872-15-91
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/04/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
The screw head broke off during implantation.The shaft of the screw remains in the patient's bone.No revisional surgery is scheduled for screw shaft removal.
Additional Manufacturer Narrative
The screw was optically assessed and stereo microscopically investigated in the lab.The stereo microscopic investigation revealed a tensile crack due to mechanical overload.Further observation determined there were no indications of material or manufacturing defects discovered.Product device history records could not be reviewed because no lot number was provided.The results of the investigation conclude that the root cause for breakage was due to mechanical overload on the screw.If further information can be gathered that might add value to the contents of the investigated report, an additional follow-up report will be submitted.

• Brand Name: MAXDRIVE MINI SCREW
• Common Device Name: BONE SREW
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 5594130
• Report Number: 9610905-2016-00010
• Device Sequence Number: 394378
• Product Code: JEY
• UDI-Device Identifier: 00888118046819
• UDI-Public: 00888118046819
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K943347
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2016

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: Health Professional
• Device Model Number: 25-872-15-91
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2016
• Supplement Report FDA Received Date: 06/30/2016
• 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
• Patient Age: 34 YR