MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG BONE FORCEPS FOR THE MANDIBULAR FRACTURE AND RECONSTRUCTION SYSTEM; INSTRUMENT

Catalog Number	92-08630
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 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 a company representative that during a surgical procedure the bone forceps broke off into a patient¿s mandible.No medical intervention and no adverse consequences were reported with this event.The procedure was completed successfully without a delay.
Additional Manufacturer Narrative
The reported event that the forceps broke off could not be confirmed as the product in question was not returned for investigation.Therefore, a detailed inspection of the device was not possible, and a root cause could not be determined.According to the risk management file, a possible root cause could have been too high bending force.This is confirmed by a previous investigation (b)(4), in which the application of too high bending forces occurred that was most likely caused by excessively trying to close the forceps.That led to a fracture within the working area.Based on statistical evaluation there is no indication for any systematic design, material, or manufacturing related issue.Therefore, no corrective and/or preventive action is deemed necessary at this time.If the product is returned at a later date or further information regarding the event is received, a thorough investigation will be performed, the complaint will be reopened, and the result revised.
Event or Problem Description
It was reported by a company representative that during a surgical procedure the bone forceps broke off into a patient¿s mandible.No medical intervention and no adverse consequences were reported with this event.The procedure was completed successfully without a delay.

• Brand Name: BONE FORCEPS FOR THE MANDIBULAR FRACTURE AND RECONSTRUCTION SYSTEM
• Common Device Name: INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 8697883
• Report Number: 0008010177-2019-00036
• Device Sequence Number: 19293854
• Product Code: LXH
• UDI-Device Identifier: 07613327174113
• UDI-Public: 07613327174113
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 11/08/2019

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 Catalogue Number: 92-08630
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 11/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1