MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG L-PLATE, 115 DEGREE, 2MM BAR, LEFT, 5 HOLE, MIDFACE; IMPLANT

Model Number	92-05560
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2020
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 by the company representative that a plate broke immediately after being bent with a modified ¿pan-fix¿ 90° bender.Plate has been removed, no remains of plate are still in patient, and the surgery was completed successfully.
Event or Problem Description
It was reported by the company representative that a plate broke immediately after being bent with a modified ¿pan-fix¿ 90° bender.Plate has been removed, no remains of plate are still in patient, and the surgery was completed successfully.
Additional Manufacturer Narrative
Because the actual plate under complaint has not been returned, the reported event could not be confirmed, and no physical investigation of that device was possible.As the lot number was not provided, a review of the specific manufacturing batch record and related quality documents (manufacturing documents, inspection plan, inspection drawing and release report) could not be performed.Therefore, it was also not possible to determine the quantity released for distribution within the affected lot.However, the investigation steps conducted and the further provided information demonstrate much evidence that the event is not related to a manufacturing issue.In order to obtain more details about the reported event, the sales rep was contacted.A picture of the modified bender was provided: 64-00190 with production code t10 ¿ manufactured in october 2003.It is an old leibinger bender that was modified by bpi medical (highly complex surgical instrument modifications for specialized procedures).The ¿v¿ of the bender is modified to be narrower.Furthermore, the plate was never fixated.The plate was completely removed from the patient, but it was never screwed down.It broke during initial bending.As clearly stated in the related ifu ¿4.Use of original products¿ implants and instruments are produced and designed to be used together.Therefore, the modified instrument is not intended to be used to bend the plate under complaint.In sum, the root cause can be attributed to an overload in terms of an off-label use.Conclusively, no indications for an incorrectly working product or any systematic design, material or manufacturing related issue were found.

• Brand Name: L-PLATE, 115 DEGREE, 2MM BAR, LEFT, 5 HOLE, MIDFACE
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• MDR Report Key: 10402956
• Report Number: 0008010177-2020-00039
• Device Sequence Number: 3669059
• Product Code: JEY
• UDI-Device Identifier: 07613154629121
• UDI-Public: 07613154629121
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 12/21/2020

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: 92-05560
• Device Catalogue Number: 92-05560
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 12/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1