MAUDE Adverse Event Report: STRYKER GMBH L COMPRESSION PROFILE PLATE, T-SHAPE, BEVELLED, NARROW, RIGHT, 6 HOLES; PLATE, FIXATION, BONE

Model Number	57-13150
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	10/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
Event or Problem Description
As reported: "on (b)(6) 2020, the patient was admitted to the hospital due to fracture of the first toe bone.On (b)(6) 2020, the patient was treated with plate combined with kirschner wire internal fixation, and was discharged after improvement.The doctor ordered regular review in the outpatient department.On (b)(6) 2021, the patient came to the outpatient department of our hospital due to the discomfort of the surgical site.The film showed that the plate was broken, and he was hospitalized immediately.On (b)(6) internal fixation was removed and kirschner wire was used for internal fixation.Postoperative condition is stable.The incident led to a second operation.".
Additional Manufacturer Narrative
Correction: please refer to d4 lot number.The reported event could not be confirmed, since the breakage of the reported t-shaped plate could not be confirmed.A device inspection was not possible since the affected device was not returned.The review of the received x-ray has shown that the shape of the visible broken plate does not correspond with the shape of the reported catalog # 57-13150.The reported plate is a t-shaped device, while on the x-ray an unknown 2-row plate is visible.Requests for clarification to the customer were made but no additional information that would clarify the discrepancy between reported plate and visible plate was made available.The only provided additional information in this relation was that no x-ray can be provided by the hospital.Therefore no further evaluation is possible.Based on the provided information was the patient not compliant with the mobilization instructions from the surgeon.The cause of the plate fracture was finally determined to be caused by the patient walking with heavy load in advance during the convalescence period.A review of the device history was not possible because the communicated lot number was invalid.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "on (b)(6)2020, the patient was admitted to the hospital due to fracture of the first toe bone.On (b)(6),2020, the patient was treated with plate combined with kirschner wire internal fixation, and was discharged after improvement.The doctor ordered regular review in the outpatient department.On (b)(6) 2021, the patient came to the outpatient department of our hospital due to the discomfort of the surgical site.The film showed that the plate was broken, and he was hospitalized immediately.On (b)(6), internal fixation was removed and kirschner wire was used for internal fixation.Postoperative condition is stable.The incident led to a second operation.".

• Brand Name: L COMPRESSION PROFILE PLATE, T-SHAPE, BEVELLED, NARROW, RIGHT, 6 HOLES
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13018917
• Report Number: 0008031020-2021-00499
• Device Sequence Number: 17440460
• Product Code: HRS
• UDI-Device Identifier: 04546540243201
• UDI-Public: 04546540243201
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K062498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 57-13150
• Device Catalogue Number: 57-13150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 78 KG