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

Model Number	51-405-42-09
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Reference exemption number e2017029.
Event or Problem Description
The device broke during the consolidation phase.Doctor believes the patient rolled over the end of the distractor in bed and the device broke.
Additional Manufacturer Narrative
An investigation was performed using visual and stereo microscopic inspection on the broken distractors returned.Process evaluation was also performed based off the lot number provided.Tensile cracks were observed under the stereo microscope.It was determined there were no indications of material or manufacturing defects.A review of the product device history records was performed on the lot number provided.In this investigation no anomalies were discovered.The results of the investigation have concluded that the root cause for breakage was due to mechanical overload on the devices.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: 6652140
• Report Number: 9610905-2017-00051
• Device Sequence Number: 19153832
• Product Code: MQN
• UDI-Device Identifier: 00888118080868
• UDI-Public: (01)00888118080868
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K010139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2017
• Report Date (Section F): 05/24/2017

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: 51-405-42-09
• Device Lot Number: 33036621
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/24/2017
• Event Location: Hospital
• Date Report to Manufacturer: 05/24/2017
• Initial Date Received by Manufacturer: 05/24/2017
• Supplement Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 06/19/2017
• Supplement Report FDA Received Date: 12/11/2017
• 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: 11 MO