MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG MINI PLATE, STRAIGHT, 4-HOLES, LONG BAR; IMPLANT

Model Number	55-10503
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2022
Type of Reportable Event	Serious Injury
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 that it was noticed during a post op scan that the plate was broken.There will be a revision surgery performed to remove the plate.
Additional Manufacturer Narrative
The device was received at the manufacturer for testing.An evaluation was conducted and the investigation results show that the postoperative plate fracture occurred through a fixing hole, so the reported event could be confirmed.No lot number was provided, thus a review of the specific manufacturing batch records and related quality documents (manufacturing documents, inspection plan, inspection drawing and release report) cannot be performed.Therefore, it is also not possible to determine the quantity released for distribution within the affected lot.Based on the investigation and the corresponding statistical evaluation there is no indication for an incorrectly working product or any systematic design, material or manufacturing related issue.
Event or Problem Description
It was reported that it was noticed during a post op scan that the plate was broken.There will be a revision surgery performed to remove the plate.

• Brand Name: MINI PLATE, STRAIGHT, 4-HOLES, LONG BAR
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: rylee koole ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 14980823
• Report Number: 0008010177-2022-00021
• Device Sequence Number: 17559268
• Product Code: JEY
• UDI-Device Identifier: 04546540366214
• UDI-Public: 04546540366214
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K022185
• 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): 12/15/2022

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
• Device Model Number: 55-10503
• Device Catalogue Number: 55-10503
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown