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

Model Number	92-08630
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/28/2019
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 that a pair of bone reduction forceps broke during a case.
Event or Problem Description
It was reported that a pair of bone reduction forceps broke during a case.
Additional Manufacturer Narrative
The reported event that a pair of bone reduction forceps broke 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 causes could have been too high bending force.This is confirmed by a previous investigation (s.Pi 1727807), in which the application of too high bending forces, most likely caused by excessively trying to close the forceps, 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 will be returned at a later date or further information regarding the event will be received, a thorough investigation will be performed, the complaint will be reopened and the result revised.H3: device not returned.

• 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; DE D-79111
• MDR Report Key: 8795088
• Report Number: 0008010177-2019-00041
• Device Sequence Number: 2838732
• Product Code: LXH
• UDI-Device Identifier: 07613327174113
• UDI-Public: 07613327174113
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/31/2020

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: 92-08630
• Device Catalogue Number: 92-08630
• Device Lot Number: 1000312841
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/28/2019
• Supplement Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 07/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1