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

Model Number	51-402-16-09
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/12/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2016 the patient's mother had difficulty making the distractor turn on the right side.The patient came into the clinic on (b)(6) 2016 where dr.(b)(6) also had difficulty turning the device on the right side.As he was asserting force to the activation arm via the patient wrench, he heard a snap.Ct concluded that the buttress tube had snapped superior to the screw connection between distractor body and buttress tube.Patient underwent surgery the same day to replace the distractor body and broken buttress tube.During the procedure the doctor retracted the distractor on the right side, and again the buttress tube broke in the same place.Buttress tube was swapped out for another.The resident and fellow thought that while retracting the distractors, the sides became in even, putting too much load on the right side making it snap.
Additional Manufacturer Narrative
Correction was made to lot number.Incorrect lot number was provided by the field however after product analysis it was confirmed by visual inspection the correct lot number.An investigation was performed using visual and stereo microscopic inspection on the broken distractors that were returned.Process evaluation was also performed based off the lot numbers.Tensile cracks were observed under the stereo microscope.Further observation determined there were no indications of material or manufacture defects.The product history device records were reviewed based on the product lot numbers and no abnormalities were found.The results of the investigation conclude that the root cause for the breakages were 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: 6230629
• Report Number: 9610905-2016-00059
• Device Sequence Number: 393632
• Product Code: MQN
• UDI-Device Identifier: 00888118080776
• UDI-Public: (01)00888118080776
• 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: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2016

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: Physician
• Device Model Number: 51-402-16-09
• Device Lot Number: 33136837, 33155374
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2017
• Supplement Report FDA Received Date: 03/03/2017
• 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