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	Failure of Implant (1924); Malunion of Bone (4529)
Date of Event	10/27/2020
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.
Event or Problem Description
It was reported by the company representative that the surgeon was made aware, post op, of the broken distractor.The patient underwent revision surgery to have the product removed and replaced and patient is doing fine.No other information is known at this time.
Additional Manufacturer Narrative
The reported event that a plate of the distractor was fractured could be confirmed based on the provided picture.The device under complaint was not returned to stryker freiburg for investigation, because it was discarded by surgical facility.Therefore, physical inspections could not be performed.This report is based on provided information and picture only.The event was discussed with the relevant r&d department.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 13 years old at the time of surgery.Therefore, the root cause of the reported failure mode was attributed to an off-label use.Indications for a design, material or manufacturing related issue could not be found in the investigation.H3: device unavailable for return.
Event or Problem Description
It was reported by the company representative that the surgeon was made aware, post op, of the broken distractor.The patient underwent revision surgery to have the product removed and replaced and patient is doing fine.No other information is known at this time.

• 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: 10836865
• Report Number: 0008010177-2020-00059
• Device Sequence Number: 3230989
• Product Code: MQN
• UDI-Device Identifier: 07613327291322
• UDI-Public: 07613327291322
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K181504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 62-02333
• Device Catalogue Number: 62-02333
• Device Lot Number: 1000371350
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 04/21/2021
• 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