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

Model Number	51-526-30-09
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/17/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the distractor was open to about 25mm and was used to retract the patients skull.After about a week the end ratchet snapped off and the device was not able to retract any further.It is believed tissue and or bone got caught in the track, which caused the device to break.Device was removed on (b)(6) 2017.Distractor was used as a retractor.The use of the device in this manner is considered off indications for use.
Additional Manufacturer Narrative
An investigation was performed using visual and stereo inspection on the returned product.The stereo microscope investigation revealed tensile cracks.Further investigation determined that there was no indication of material or manufacturing defects observed.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 the root cause for the device breaking was cue 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: 6411143
• Report Number: 9610905-2017-00035
• Device Sequence Number: 18997362
• Product Code: MQN
• UDI-Device Identifier: 00888118099617
• UDI-Public: (01)00888118099617
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2017

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: 51-526-30-09
• Device Lot Number: 33177251
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/17/2017
• Supplement Date Received by Manufacturer: 02/17/2017
• Initial Report FDA Received Date: 03/16/2017
• 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: 2 YR