MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG IN-SITU PLATE CUTTER, UPPERFACE/MIDFACE; INSTRUMENT

Model Number	62-18330
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received at the manufacturer for testing.An evaluation will be conducted, 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 while trying to cut a hole in he plate, the tip of the blade broke off.
Event or Problem Description
It was reported by the company representative that while trying to cut a hole in he plate, the tip of the blade broke off.
Additional Manufacturer Narrative
The reported event that the tips broke off could not be confirmed, because the device was not returned to freiburg for investigation.Because the device was scrapped, no visual, functional nor dimensional inspection was performed.To gain further information about the reported event, the sales rep was contacted.He didn¿t note the missing lot# before the device has been shipped.L-plate (catalog # 55-07767) and 2.0 mp plate (catalog # 92-92306) have been cut with the instrument under complaint and all broken off fragments of the cutter were retrieved from the patient.The mentioned l-plate has a profile height of 0.8mm and the mp plate has a profile height of 1.0mm.The laser marking on the cutter (s.Fig.1 and 2) restricts the use of the cutter for cutting plates up to a height of 0.6mm.Therefore, the cutter has been used for cutting inappropriate implants.Indications for any material, manufacturing or design related problems were not determined in the investigation.Therefore, no further preventive and / or corrective action is required at this time.H3 other text : device not available for return.

• Brand Name: IN-SITU PLATE CUTTER, UPPERFACE/MIDFACE
• Common Device Name: INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• MDR Report Key: 11151008
• Report Number: 0008010177-2021-00001
• Device Sequence Number: 2870595
• Product Code: LXH
• UDI-Device Identifier: 04546540366719
• UDI-Public: 04546540366719
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 04/22/2021

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: 62-18330
• Device Catalogue Number: 62-18330
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/31/2020
• Supplement Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other