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

Model Number	62-18330
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2021
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 during the surgical procedure, the spring on the device broke.
Additional Manufacturer Narrative
The reported event in terms of a broken spring could be confirmed, and it was found after the investigation that the spring was only disassembled and missing, and no sharp edges were present.The elastic opening/closing function of the in-situ plate cutter is not given anymore.Most likely, the in-situ plate cutter was used to cut hybrid arch bars, but the sales rep was not present in that case, so there is no confirmation.The in-situ plate cutter is intended to cut the arch bars of the hybrid mmf plates system.A possible root cause for the loosening of the spring could have been too wide opening of the device as the spring is held by a ring groove that surrounds a pin in the arms.As the spring was not part of the returned device, it could not be examined to determine if the spring shows any damage contributing to the failure mode.Based on the new information provided it has been determined that the actual line item to be #3301 which is a s1, o4 event.In conclusion, a certain root cause for the detachment/missing of the spring could not be determined.
Event or Problem Description
It was reported by the company representative that during the surgical procedure, the spring on the device broke.

• 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: 12068367
• Report Number: 0008010177-2021-00037
• Device Sequence Number: 3577535
• Product Code: LXH
• UDI-Device Identifier: 04546540366719
• UDI-Public: 04546540366719
• 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): 08/03/2021

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: AG07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 06/25/2021
• Supplement Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1