MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PEDIATRIC MANDIBULAR DISTRACTOR 2, 3X3 RIGHT PLATES, 30 MM; IMPLANT

Model Number	62-02333
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
Event or Problem Description
It was reported that during removal of the distractor, the rod broke at the ball joint.
Additional Manufacturer Narrative
The reported event that the distractor rod broke at the ball joint could be confirmed based on the returned parts of the affected distractors.For visual inspection only parts of both distractors were returned.Therefore, no functional inspection could be performed nor a dimensional inspection was deemed necessary.As stated in the related instruction for use the pediatric mandibular distractor 2 is indicated to correct congenital or post traumatic defects in the body and ramus of the mandible of neonates and children up to 4 years old.In accordance to the provided information the patient was treated in the cranial area.It was confirmed that the surgeon was aware of the off-label use ¿but he wanted to use it because he likes the fact that it¿s milled out of one piece of metal¿.Additionally, it was confirmed that the root cause was ¿definitely uncontrolled movement of the patient.The devices were not taped down or stabilized.The patient had full range of motion and was able to grab on to the devices.¿therefore, the root cause of the failure modes was attributed to an off-label use.
Event or Problem Description
It was reported that during removal of the distractor, the rod broke at the ball joint.

• Brand Name: PEDIATRIC MANDIBULAR DISTRACTOR 2, 3X3 RIGHT PLATES, 30 MM
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• MDR Report Key: 11741251
• Report Number: 0008010177-2021-00024
• Device Sequence Number: 16949810
• Product Code: MQN
• UDI-Device Identifier: 07613327291322
• UDI-Public: 07613327291322
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K181504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2021

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: 62-02333
• Device Catalogue Number: 62-02333
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Initial Date Received by Manufacturer: 04/02/2021
• Supplement Date Received by Manufacturer: 04/02/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1