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

Model Number 92-05560

Device Problem Fracture (1260)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2020

Event Type  malfunction  

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 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 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.

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
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• MDR Report Key: 10402956
• MDR Text Key: 203641562
• Report Number: 0008010177-2020-00039
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07613154629121
• UDI-Public: 07613154629121
• Combination Product (y/n): N
• PMA/PMN Number: K022185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1