MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PEDIATRIC MANDIBULAR DISTRACTOR 2, 2X2 RIGHT PLATES, 20 MM

Model Number	62-02321
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Device is implanted.
Event or Problem Description
It was reported that during turn of the device, the pmd came apart inside of the patient resulting in the device breaking into two pieces with the internal mechanism completely unattached.There were no adverse consequences reported and there is no other information known at this time.
Additional Manufacturer Narrative
Within the visual examination of the provided picture as well as the returned device components it was revealed that the distractor rod was broken at the anti-reverse mechanism area and the anti-reverse mechanism was still activated fixating the broken of distraction rod part.After demounting of the distraction rod part out of the anti-reverse mechanism, a heavy pressure mark was found.This pressure mark resulted from high torsional forces by turning the distraction rod in counterclockwise direction in combination with an activated locking mechanism.This resulted in the breakage of the distraction rod.The breakage surface shows the appearance of a forced rupture due to too high torsional forces.Based on the performed technical investigation of the returned device components the root cause could be clearly identified and attributed to a usage related handling issue by turning the device in the wrong direction (counterclockwise) instead of correct direction (clockwise).
Event or Problem Description
It was reported that during turn of the device, the pmd came apart inside of the patient resulting in the device breaking into two pieces with the internal mechanism completely unattached.There were no adverse consequences reported and there is no other information known at this time.

• Brand Name: PEDIATRIC MANDIBULAR DISTRACTOR 2, 2X2 RIGHT PLATES, 20 MM
• Common Device Name: DISTRACTOR
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• MDR Report Key: 11398927
• Report Number: 0008010177-2021-00015
• Device Sequence Number: 17190899
• Product Code: MQN
• UDI-Device Identifier: 07613327291384
• UDI-Public: 07613327291384
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K181504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 62-02321
• Device Catalogue Number: 62-02321
• Device Lot Number: 1000370171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 07/09/2021
• 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: Required Intervention