MAUDE Adverse Event Report: STRYKER GMBH DISTAL MEDIAL HUMERUS PLATE - EXTENDED VARIAX LEFT / RIGHT HUMERUS 3 HOLE / L; PLATE, FIXATION, BONE

Model Number	629283S
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	04/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "the patient's infection, the second distal screw came off, so a revision operation was performed on (b)(6).After the skin was cut, the second and third screws that had entered the distal area were removed, washed, and an attempt was made to insert the screw into the second screw hole again, but the bone was lost and the insertion was abandoned.Since the screw contained in the distal bone fragment would disappear as it is, i tried to insert at least the third screw from the distal side, and opened and inserted a new screw shorter than the originally inserted screw, but it did not lock.I reinserted it into the hole that had already been opened, but it did not lock, so this is my request for investigation.Also, please check the place where the second one comes out from the distal side.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history, including a review of this irradiation certificate of the sterilization process, for the reported lot did not indicate any abnormalities.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: "the patient's infection, the second distal screw came off, so a revision operation was performed on april 5.After the skin was cut, the second and third screws that had entered the distal area were removed, washed, and an attempt was made to insert the screw into the second screw hole again, but the bone was lost and the insertion was abandoned.Since the screw contained in the distal bone fragment would disappear as it is, i tried to insert at least the third screw from the distal side, and opened and inserted a new screw shorter than the originally inserted screw, but it did not lock.I reinserted it into the hole that had already been opened, but it did not lock, so this is my request for investigation.Also, please check the place where the second one comes out from the distal side.".

• Brand Name: DISTAL MEDIAL HUMERUS PLATE - EXTENDED VARIAX LEFT / RIGHT HUMERUS 3 HOLE / L
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11753600
• Report Number: 0008031020-2021-00202
• Device Sequence Number: 17178331
• Product Code: HRS
• UDI-Device Identifier: 07613327082401
• UDI-Public: 07613327082401
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141677
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2021

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 Expiration Date: 05/31/2021
• Device Model Number: 629283S
• Device Catalogue Number: 629283S
• Device Lot Number: V25523
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 06/11/2021
• 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: Required Intervention