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

Model Number	51-563-30-09
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	02/06/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient came to the clinic with device broken along the drive shaft.This is the second device that has broken in the patient.Previous event was reported on mdr 9610905-2016-00058.Doctor believes the patient broke this and previous device due to abrasion/punctures observed on arm and hand from hitting the device.Third surgery is planned for (b)(6) 2017 to remove the distraction.
Additional Manufacturer Narrative
An investigation was performed using visual and stereo microscopic inspection.The stereo microscope investigation revealed tensile cracks.Further observation determined there were no indications of material or manufacturing defects.A review of the product device history files was performed based on the lot number provided.No discrepancies were found in this investigation.The results of the investigation have concluded the root cause for the device breaking was due to strain on the device which caused mechanical stress.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: 6384605
• Report Number: 9610905-2017-00029
• Device Sequence Number: 18960893
• Product Code: MQN
• UDI-Device Identifier: 00888118082145
• UDI-Public: 00888118082145
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K010139
• 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): 02/06/2017

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: 51-563-30-09
• Device Lot Number: 33169560
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/06/2017
• Supplement Date Received by Manufacturer: 02/06/2017
• Initial Report FDA Received Date: 03/07/2017
• Supplement Report FDA Received Date: 09/13/2017
• 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: 4 YR