MAUDE Adverse Event Report: STRYKER GMBH ANTERIOR MIDSHAFT PLATE VARIAX CLAVICLE 7 HOLE; PLATE, FIXATION, BONE

Catalog Number	628307
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Remains implanted.
Event or Problem Description
It was reported that after patient fell, a 7-hole anterior midshaft plate on the patient's clavicle broke at a hole where a screw is located.Patient has not yet been revised.
Additional Manufacturer Narrative
The reported event that anterior midshaft plate variax clavicle 7 hole was alleged of 'implant breakage after surgery' could be confirmed.Based on investigation, the root cause was attributed to be patient related.The failure was caused by the fall of the patient.Indeed, the implant is not supposed to withstand this kind of peak loads.It is clearly stated in the ifu that : "[.] informing the patient the implantation affects the patient¿s ability to carry loads and her/his mobility and general living circumstances.For this reason, the surgeon must counsel each patient individually on correct behavior and activity after the implantation.The surgeon must warn patient that the device cannot and does not replicate a normal healthy bone, that the device can break or become damaged as a result of strenuous activity, trauma, mal-union or nonunion and that the device has a finite expected service life and may need to be removed at some time in the future.Explain the need to report unusual changes in the implantation area as well as falls or accidents even if the device or the site of operation did not appear to be harmed at the time.[.]" the plate was returned, and is indeed broken at the level of the third hole.When put together, the two pieces show that the plate was severely bent.The analysis of the brakeage surface shows very clear breakage lines, and a large tear-off surface.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.If any further information is provided, the investigation report will be updated.
Event or Problem Description
It was reported that after patient fell, a 7-hole anterior midshaft plate on the patient's clavicle broke at a hole where a screw is located.Patient has not yet been revised.

• Brand Name: ANTERIOR MIDSHAFT PLATE VARIAX CLAVICLE 7 HOLE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7986132
• Report Number: 0008031020-2018-00879
• Device Sequence Number: 10805643
• Product Code: HRS
• UDI-Device Identifier: 07613252442424
• UDI-Public: 07613252442424
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K113760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2018

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 Catalogue Number: 628307
• Device Lot Number: L24314
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/22/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 12/28/2018
• 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: Other
• Patient Age: 21 YR