MAUDE Adverse Event Report: STRYKER GMBH SUPERIOR PLATE - DECREASED CURVATURE VARIAX CLAVICLE 8 HOLE / LEFT; PLATE, FIXATION, BONE

Catalog Number	628008
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/02/2019
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: "treated revision surgery due to back out of screws.Replaces plate the screw.".
Event or Problem Description
As reported: "treated revision surgery due to back out of screws.Replaces plate the screw.".
Additional Manufacturer Narrative
The reported event could be confirmed (in addition to the returned sample; x-rays were also provided).The device inspection revealed the following: plate: some close ups of the screw holes, from left to right, show that the two locking holes on the left side are indeed badly damaged.The locking hole from the far right side is just slightly damaged, no damage was observed with the other holes.Screws: damages on the locking threads are clearly visible though.Test using the existing locking screws showed that the two screws from the left side could be locked but they would not hold accordingly due to the severe damages (on the plate as well as on the locking threads).The other two locking screws could be locked without any issues.No issues with the bone screws.A statement was received from our medical expert and is noted below: in the postoperative x-ray we see, that the three lateral screws are tied to the lateral clavicle end.The most medial of them is fixed at the fracture location.At least the proximal cortex seems to be not intact.So, we only have five cortices which are gripped by the threads of the screw.With the movements associated with the shoulder girdle including the clavicle, that was obviously not enough to stabilize the fracture securely and lead to union.A longer plate with at least one more lateral hole would have been better, knowing the result of the treatment.A review of the device history 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.Based on investigation, the root cause was attributed to be user/patient related.The exact cause of the failure could not be determined as no further details could be obtained.If any further information is provided, the investigation report will be updated.

• Brand Name: SUPERIOR PLATE - DECREASED CURVATURE VARIAX CLAVICLE 8 HOLE / LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9108826
• Report Number: 0008031020-2019-01304
• Device Sequence Number: 449581
• Product Code: HRS
• UDI-Device Identifier: 07613252441885
• UDI-Public: 07613252441885
• Combination Product (Y/N): N
• PMA/510(K) Number: K113760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2019

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: 02/29/2024
• Device Catalogue Number: 628008
• Device Lot Number: D24119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Initial Date Received by Manufacturer: 09/02/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 12/09/2019
• 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