MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG DISTRACTION, INTERNAL; DISTRACTOR

Model Number	51-424-25-09
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/12/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Guardian of patient was making final 1mm turn with the patient screwdriver and the device broke.Doctor forrest reported the patient's completely fine, no negative effects occurred.Doctor forrest thinks it may be a case of the parent trying with too much force to distract the device with the patient screwdriver when it's possible the device has already completed its full distraction potential.
Additional Manufacturer Narrative
An investigation was performed using visual and stereo microscopic inspection on the returned product.Process evaluation was also completed on the lot number provided.Tensile cracks were observed under the stereo microscope.It was determined there were no indications of material or manufacturing defects.During the investigation the product lot number provided was reviewed in the device history records.The dhr review showed no discrepancies or anomalies.The results of the investigation have concluded that the root cause for breakage was due to mechanical overload on the device.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: DISTRACTION, INTERNAL
• Common Device Name: DISTRACTOR
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 6335733
• Report Number: 9610905-2017-00027
• Device Sequence Number: 977123
• Product Code: MQN
• UDI-Device Identifier: 00888118081278
• UDI-Public: (01)00888118081278
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K010139
• 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): 01/20/2017

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?: Yes
• Operator of Device: Physician
• Device Model Number: 51-424-25-09
• Device Lot Number: 33067451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/20/2017
• Supplement Date Received by Manufacturer: 10/18/2017
• Initial Report FDA Received Date: 02/16/2017
• Supplement Report FDA Received Date: 11/08/2017
• 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
• Patient Age: 8 MO