MAUDE Adverse Event Report: STRYKER GMBH SUPERIOR PLATE - DECREASED CURVATURE VARIAX CLAVICLE 7 HOLE / LEFT; PLATE, FIXATION, BONE

Model Number	628007S
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Codes	Failure of Implant (1924); Impaired Healing (2378)
Date of Event	10/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "a (b)(6)-year-old female pt underwent the clavicle joint surgery (left) on (b)(6) 2020.After the operation, the plate moved and the screw came off the plate, and the revision surgery was performed on (b)(6) 2020.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received plate found completely intact with no deformation.The hole where bone screw was placed observed without any defects on its surface.However, the hole where locking screw was placed was observed with minor chipping off, of the metals at rim due to insertion of locking screw.The inspection does not indicate any device related issue for the reported failure.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on investigation, the root cause was attributed to a patient related issue.The failure was caused due to screws did not hold to the specified location which resulted in separation of screws from the plate.Considering the age of the patient & opinion from the sr, failure mode is more attributable to patient related ( weak bone quality, patient activity etc.) if any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "a 90-year-old female pt underwent the clavicle joint surgery (left) on (b)(6) 2020.After the operation, the plate moved and the screw came off the plate, and the revision surgery was performed on (b)(6) 2020".
Event or Problem Description
As reported: "a 90-year-old female pt underwent the clavicle joint surgery (left) on (b)(6) 2020.After the operation, the plate moved and the screw came off the plate, and the revision surgery was performed on (b)(6) 2020.".
Additional Manufacturer Narrative
Please note corrections to clinical sign code h6, results code h6.

• Brand Name: SUPERIOR PLATE - DECREASED CURVATURE VARIAX CLAVICLE 7 HOLE / LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10884971
• Report Number: 0008031020-2020-02491
• Device Sequence Number: 3317450
• Product Code: HRS
• UDI-Device Identifier: 04546540686862
• UDI-Public: 04546540686862
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2021

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: 11/30/2024
• Device Model Number: 628007S
• Device Catalogue Number: 628007S
• Device Lot Number: D55485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 12/31/2020; 01/28/2021
• Initial Report FDA Received Date: 11/23/2020
• Supplement Report FDA Received Date: 01/27/2021; 01/29/2021
• 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